Trial Outcomes & Findings for Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD). (NCT NCT00523991)
NCT ID: NCT00523991
Last Updated: 2014-05-20
Results Overview
Change = Week 24 Value - Baseline Value
COMPLETED
PHASE4
457 participants
baseline, week 24
2014-05-20
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo matching tiotropium via HandiHaler® + Pro Re Nata (PRN) albuterol
|
Tiotropium
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Overall Study
STARTED
|
219
|
238
|
|
Overall Study
COMPLETED
|
198
|
211
|
|
Overall Study
NOT COMPLETED
|
21
|
27
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matching tiotropium via HandiHaler® + Pro Re Nata (PRN) albuterol
|
Tiotropium
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
5
|
|
Overall Study
Protocol Violation
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
17
|
|
Overall Study
Other reason (not specified)
|
3
|
0
|
Baseline Characteristics
Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).
Baseline characteristics by cohort
| Measure |
Placebo
n=219 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=238 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
Total
n=457 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 8.6 • n=99 Participants
|
61.2 years
STANDARD_DEVIATION 8.2 • n=107 Participants
|
61.7 years
STANDARD_DEVIATION 8.4 • n=206 Participants
|
|
Age, Customized
18-44 years
|
8 participants
n=99 Participants
|
7 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Age, Customized
45-64 years
|
121 participants
n=99 Participants
|
151 participants
n=107 Participants
|
272 participants
n=206 Participants
|
|
Age, Customized
>=65 years
|
90 participants
n=99 Participants
|
80 participants
n=107 Participants
|
170 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
144 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
147 Participants
n=99 Participants
|
166 Participants
n=107 Participants
|
313 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 participants
n=99 Participants
|
4 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
213 participants
n=99 Participants
|
234 participants
n=107 Participants
|
447 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline, week 24Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change = Week 24 Value - Baseline Value
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h)
|
-0.06 litres * hours
Standard Error 0.02
|
0.16 litres * hours
Standard Error 0.02
|
SECONDARY outcome
Timeframe: BaselinePopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline)
|
1.71 litres
Standard Deviation 0.45
|
1.74 litres
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: Baseline, week 8Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8)
|
-0.03 litres
Standard Deviation 0.21
|
0.12 litres
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: Baseline, week 16Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16)
|
-0.06 litres
Standard Deviation 0.21
|
0.09 litres
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: Baseline, week 24Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24)
|
-0.08 litres
Standard Error 0.02
|
0.06 litres
Standard Error 0.02
|
SECONDARY outcome
Timeframe: BaselinePopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Peak Forced Expiratory Volume in 1 Second (Baseline)
|
1.71 litres
Standard Deviation 0.45
|
1.74 litres
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: Baseline, week 8Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8)
|
0.09 litres
Standard Deviation 0.22
|
0.31 litres
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: Baseline, week 16Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16)
|
0.05 litres
Standard Deviation 0.24
|
0.29 litres
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: Baseline, week 24Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24)
|
0.02 litres
Standard Error 0.02
|
0.26 litres
Standard Error 0.02
|
SECONDARY outcome
Timeframe: BaselinePopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Forced expiratory volume in 1 second (baseline, pre-dose)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Forced Expiratory Volume in 1 Second (Baseline, Pre-dose)
|
1.71 litres
Standard Deviation 0.45
|
1.74 litres
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: baseline, 30 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Forced expiratory volume in 1 second (baseline, 30 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes)
|
1.73 litres
Standard Deviation 0.45
|
1.87 litres
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: baseline, 60 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Forced expiratory volume in 1 second (baseline, 60 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes)
|
1.74 litres
Standard Deviation 0.47
|
1.90 litres
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: Baseline, 120 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Forced expiratory volume in 1 second (baseline, 120 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes)
|
1.75 litres
Standard Deviation 0.48
|
1.92 litres
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: Baseline, 180 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Forced expiratory volume in 1 second (baseline, 180 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes)
|
1.76 litres
Standard Deviation 0.48
|
1.94 litres
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: baseline, week 8, pre-dosePopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in forced expiratory volume in 1 second (at week 8, pre-dose)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose)
|
-0.03 litres
Standard Deviation 0.21
|
0.12 litres
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: Baseline, week 8, 30 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in forced expiratory volume in 1 second (at week 8, 30 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes)
|
0.00 litres
Standard Deviation 0.22
|
0.20 litres
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: baseline, week 8, 60 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in forced expiratory volume in 1 second (at week 8, 60 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes)
|
0.01 litres
Standard Deviation 0.24
|
0.22 litres
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: baseline, week 8, 120 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in forced expiratory volume in 1 second (at week 8, 120 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes)
|
0.01 litres
Standard Deviation 0.23
|
0.24 litres
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: baseline, week 8, 180 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in forced expiratory volume in 1 second (at week 8, 180 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes)
|
0.01 litres
Standard Deviation 0.22
|
0.24 litres
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: baseline, week 16, pre-dosePopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in forced expiratory volume in 1 second (at week 16, pre-dose)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose)
|
-0.06 litres
Standard Deviation 0.21
|
0.09 litres
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: Baseline, week 16, 30 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in peak forced expiratory volume in 1 second (at week 16, 30 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes)
|
-0.02 litres
Standard Deviation 0.24
|
0.19 litres
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: baseline, week 16, 60 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in peak forced expiratory volume in 1 second (at week 16, 60 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes)
|
-0.02 litres
Standard Deviation 0.24
|
0.21 litres
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: baseline, week 16, 120 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in peak forced expiratory volume in 1 second (at week 16, 120 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes)
|
-0.03 litres
Standard Deviation 0.24
|
0.22 litres
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: baseline, week 16, 180 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in peak forced expiratory volume in 1 second (at week 16, 180 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes)
|
-0.02 litres
Standard Deviation 0.24
|
0.22 litres
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: baseline, week 24, pre-dosePopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in peak forced expiratory volume in 1 second (at week 24, pre-dose)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose)
|
-0.08 litres
Standard Error 0.02
|
0.06 litres
Standard Error 0.02
|
SECONDARY outcome
Timeframe: baseline, week 24, 30 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in peak forced expiratory volume in 1 second (at week 24, 30 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes)
|
-0.05 litres
Standard Error 0.02
|
0.15 litres
Standard Error 0.02
|
SECONDARY outcome
Timeframe: baseline, week 24, 60 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in peak forced expiratory volume in 1 second (at week 24, 60 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes)
|
-0.05 litres
Standard Error 0.02
|
0.18 litres
Standard Error 0.02
|
SECONDARY outcome
Timeframe: baseline, week 24, 120 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in peak forced expiratory volume in 1 second (at week 24, 120 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes)
|
-0.06 litres
Standard Error 0.02
|
0.18 litres
Standard Error 0.02
|
SECONDARY outcome
Timeframe: baseline, week 24, 180 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in peak forced expiratory volume in 1 second (at week 24, 180 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes)
|
-0.05 litres
Standard Error 0.02
|
0.20 litres
Standard Error 0.02
|
SECONDARY outcome
Timeframe: baselinePopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
FVC AUC0-3 at Baseline
|
3.17 litres * hours
Standard Deviation 0.82
|
3.24 litres * hours
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: baseline, week 8Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 8)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
FVC AUC0-3 at Week 8 Minus Baseline
|
-0.01 litres * hours
Standard Deviation 0.35
|
0.28 litres * hours
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: baseline, week 16Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)(week 16)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
FVC AUC0-3 at Week 16 Minus Baseline
|
-0.06 litres * hours
Standard Deviation 0.39
|
0.24 litres * hours
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: baseline, week 24Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 24)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
FVC AUC0-3 at Week 24 Minus Baseline
|
-0.11 litres * hours
Standard Error 0.03
|
0.19 litres * hours
Standard Error 0.03
|
SECONDARY outcome
Timeframe: baselinePopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Trough Forced Vital Capacity (Baseline)
|
3.17 litres
Standard Deviation 0.82
|
3.24 litres
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: baseline, week 8Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Trough Forced Vital Capacity (at Week 8)
|
-0.06 litres
Standard Deviation 0.33
|
0.16 litres
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: baseline, week 16Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Trough Forced Vital Capacity (at Week 16)
|
-0.13 litres
Standard Deviation 0.37
|
0.10 litres
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: baseline, week 24Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Trough Forced Vital Capacity (at Week 24)
|
-0.14 litres
Standard Error 0.03
|
0.07 litres
Standard Error 0.03
|
SECONDARY outcome
Timeframe: baselinePopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Peak Forced Vital Capacity (FVC) (Baseline)
|
3.17 litres
Standard Deviation 0.82
|
3.24 litres
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: baseline, week 8Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Peak Forced Vital Capacity (at Week 8)
|
0.13 litres
Standard Deviation 0.34
|
0.43 litres
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: baseline, week 16Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Peak Forced Vital Capacity (at Week 16)
|
0.08 litres
Standard Deviation 0.40
|
0.38 litres
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: baseline, week 24Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Peak Forced Vital Capacity (at Week 24)
|
0.06 litres
Standard Error 0.04
|
0.40 litres
Standard Error 0.04
|
SECONDARY outcome
Timeframe: baselinePopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Forced vital capacity (baseline, pre-dose)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Forced Vital Capacity (Baseline, Pre-dose)
|
3.17 litres
Standard Deviation 0.82
|
3.24 litres
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: baseline, 30 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Forced vital capacity (baseline, 30 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Forced Vital Capacity (Baseline, 30 Minutes)
|
3.20 litres
Standard Deviation 0.82
|
3.45 litres
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: baseline, 60 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Forced vital capacity (baseline, 60 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Forced Vital Capacity (Baseline, 60 Minutes)
|
3.22 litres
Standard Deviation 0.85
|
3.48 litres
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: baseline, 120 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Forced vital capacity (baseline, 120 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Forced Vital Capacity (Baseline, 120 Minutes)
|
3.21 litres
Standard Deviation 0.86
|
3.49 litres
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: baseline, 180 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Forced vital capacity (baseline, 180 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Forced Vital Capacity (Baseline, 180 Minutes)
|
3.21 litres
Standard Deviation 0.83
|
3.50 litres
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: baseline, week 8, pre-dosePopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in forced vital capacity (week 8, pre-dose)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose)
|
-0.06 litres
Standard Deviation 0.33
|
0.16 litres
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: baseline, week 8, 30 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in forced vital capacity (week 8, 30 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes)
|
0.00 litres
Standard Deviation 0.35
|
0.27 litres
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: baseline, week 8, 60 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in forced vital capacity (week 8, 60 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes)
|
0.00 litres
Standard Deviation 0.37
|
0.29 litres
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: baseline, week 8, 120 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in forced vital capacity (week 8, 120 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes)
|
-0.02 litres
Standard Deviation 0.39
|
0.30 litres
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: baseline, week 8, 180 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in forced vital capacity (week 8, 180 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes)
|
0.00 litres
Standard Deviation 0.37
|
0.30 litres
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: baseline, week 16, pre-dosePopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in forced vital capacity (week 16, pre-dose)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose)
|
-0.13 litres
Standard Deviation 0.37
|
0.10 litres
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: baseline, week 16, 30 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in forced vital capacity (week 16, 30 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes)
|
-0.06 litres
Standard Deviation 0.39
|
0.24 litres
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: baseline, week 16, 60 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in forced vital capacity (week 16, 60 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes)
|
-0.05 litres
Standard Deviation 0.41
|
0.27 litres
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: baseline, week 16, 120 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in forced vital capacity (week 16, 120 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes)
|
-0.05 litres
Standard Deviation 0.41
|
0.26 litres
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: baseline, week 16, 180 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in forced vital capacity (week 16, 180 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes)
|
-0.05 litres
Standard Deviation 0.42
|
0.26 litres
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: baseline, week 24, pre-dosePopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in forced vital capacity (week 24, pre-dose)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose)
|
-0.14 litres
Standard Error 0.03
|
0.07 litres
Standard Error 0.03
|
SECONDARY outcome
Timeframe: baseline, week 24, 30 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in forced vital capacity (week 24, 30 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes)
|
-0.10 litres
Standard Error 0.03
|
0.19 litres
Standard Error 0.03
|
SECONDARY outcome
Timeframe: baseline, week 24, 60 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in forced vital capacity (week 24, 60 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes)
|
-0.07 litres
Standard Error 0.03
|
0.23 litres
Standard Error 0.03
|
SECONDARY outcome
Timeframe: baseline, week 24, 120 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in forced vital capacity (week 24, 120 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes)
|
-0.11 litres
Standard Error 0.03
|
0.22 litres
Standard Error 0.03
|
SECONDARY outcome
Timeframe: baseline, week 24, 180 minutesPopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Change from baseline in forced vital capacity (week 24, 180 minutes)
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes)
|
-0.07 litres
Standard Error 0.04
|
0.29 litres
Standard Error 0.04
|
SECONDARY outcome
Timeframe: baselinePopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Number of days that participants used albuterol prn per week
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Albuterol Use p.r.n. (Baseline)
|
2.1 days
Standard Deviation 2.76
|
1.8 days
Standard Deviation 2.63
|
SECONDARY outcome
Timeframe: baseline, week 4Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Difference in number of days that participants used albuterol prn per week between week 4 and baseline
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Albuterol Use p.r.n. - (Week 4)
|
-0.2 days
Standard Deviation 1.71
|
-0.2 days
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: baseline, week 8Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Difference in number of days that participants used albuterol prn per week between week 8 and baseline
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=225 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Albuterol Use p.r.n. - (Week 8)
|
-0.3 days
Standard Deviation 2.13
|
-0.3 days
Standard Deviation 1.96
|
SECONDARY outcome
Timeframe: baseline, week 12Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Difference in number of days that participants used albuterol prn per week between week 12 and baseline
Outcome measures
| Measure |
Placebo
n=206 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=220 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Albuterol Use p.r.n. -(Week 12)
|
-0.3 days
Standard Deviation 2.16
|
-0.3 days
Standard Deviation 2.09
|
SECONDARY outcome
Timeframe: baseline, week 16Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Difference in number of days that participants used albuterol prn per week between week 16 and baseline
Outcome measures
| Measure |
Placebo
n=203 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=215 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Albuterol Use p.r.n. - (Week 16)
|
-0.4 days
Standard Deviation 2.10
|
-0.3 days
Standard Deviation 2.26
|
SECONDARY outcome
Timeframe: baseline, week 20Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Difference in number of days that participants used albuterol prn per week between week 20 and baseline
Outcome measures
| Measure |
Placebo
n=201 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=212 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Albuterol Use p.r.n. -(Week 20)
|
-0.4 days
Standard Deviation 2.34
|
-0.3 days
Standard Deviation 2.21
|
SECONDARY outcome
Timeframe: baseline, week 24Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
Difference in number of days that participants used albuterol prn per week between week 24 and baseline
Outcome measures
| Measure |
Placebo
n=201 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=216 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Albuterol Use p.r.n. - (Week 24)
|
-0.64 days
Standard Error 0.18
|
-0.62 days
Standard Error 0.17
|
SECONDARY outcome
Timeframe: baselinePopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Outcome measures
| Measure |
Placebo
n=207 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline)
Poor/Fair
|
62 Participants
|
78 Participants
|
|
Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline)
Good
|
122 Participants
|
132 Participants
|
|
Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline)
Excellent
|
23 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: week 12Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Outcome measures
| Measure |
Placebo
n=204 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=220 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12)
Poor/Fair
|
49 Participants
|
50 Participants
|
|
Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12)
Good
|
135 Participants
|
134 Participants
|
|
Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12)
Excellent
|
20 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: week 24Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Outcome measures
| Measure |
Placebo
n=201 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=216 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24)
Poor/Fair
|
51 Participants
|
41 Participants
|
|
Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24)
Good
|
128 Participants
|
136 Participants
|
|
Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24)
Excellent
|
22 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: baselinePopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Outcome measures
| Measure |
Placebo
n=206 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline)
Poor/Fair
|
72 Participants
|
95 Participants
|
|
Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline)
Good
|
111 Participants
|
117 Participants
|
|
Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline)
Excellent
|
23 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: week 12Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Outcome measures
| Measure |
Placebo
n=206 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=220 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12)
Poor/Fair
|
62 Participants
|
53 Participants
|
|
Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12)
Good
|
127 Participants
|
132 Participants
|
|
Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12)
Excellent
|
17 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: week 24Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Outcome measures
| Measure |
Placebo
n=201 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=216 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24)
Poor/Fair
|
66 Participants
|
56 Participants
|
|
Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24)
Good
|
116 Participants
|
128 Participants
|
|
Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24)
Excellent
|
19 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: baselinePopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.
Outcome measures
| Measure |
Placebo
n=206 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=227 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline)
|
25.4 units on a scale
Standard Deviation 21.43
|
28 units on a scale
Standard Deviation 22.32
|
SECONDARY outcome
Timeframe: baseline, week 4Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.
Outcome measures
| Measure |
Placebo
n=205 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=225 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4)
|
0.34 units on a scale
Standard Error 1.64
|
0.98 units on a scale
Standard Error 1.53
|
SECONDARY outcome
Timeframe: baseline, week 8Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.
Outcome measures
| Measure |
Placebo
n=206 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=225 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8)
|
2.12 units on a scale
Standard Error 1.54
|
-0.38 units on a scale
Standard Error 1.44
|
SECONDARY outcome
Timeframe: baseline, week 12Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.
Outcome measures
| Measure |
Placebo
n=205 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=217 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12)
|
-0.54 units on a scale
Standard Error 1.58
|
-1.07 units on a scale
Standard Error 1.51
|
SECONDARY outcome
Timeframe: baseline, week 16Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.
Outcome measures
| Measure |
Placebo
n=200 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=214 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16)
|
4.47 units on a scale
Standard Error 1.64
|
2.62 units on a scale
Standard Error 1.54
|
SECONDARY outcome
Timeframe: baseline, week 20Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.
Outcome measures
| Measure |
Placebo
n=200 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=211 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20)
|
4.32 units on a scale
Standard Error 1.62
|
3.52 units on a scale
Standard Error 1.70
|
SECONDARY outcome
Timeframe: baseline, week 24Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.
Outcome measures
| Measure |
Placebo
n=198 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=215 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24)
|
5.26 units on a scale
Standard Error 1.64
|
1.51 units on a scale
Standard Error 1.54
|
SECONDARY outcome
Timeframe: baselinePopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.
Outcome measures
| Measure |
Placebo
n=75 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=89 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health
|
17.2 units on a scale
Standard Deviation 20.24
|
21.1 units on a scale
Standard Deviation 21.08
|
SECONDARY outcome
Timeframe: baseline, week 4Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.
Outcome measures
| Measure |
Placebo
n=69 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=83 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 4)
|
-2.03 units on a scale
Standard Error 2.21
|
-2.64 units on a scale
Standard Error 2.03
|
SECONDARY outcome
Timeframe: baseline, week 8Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.
Outcome measures
| Measure |
Placebo
n=68 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=77 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 8)
|
0.41 units on a scale
Standard Error 2.71
|
-0.61 units on a scale
Standard Error 2.60
|
SECONDARY outcome
Timeframe: baseline, week 12Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.
Outcome measures
| Measure |
Placebo
n=68 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=76 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 12)
|
-0.32 units on a scale
Standard Error 1.91
|
0.46 units on a scale
Standard Error 1.84
|
SECONDARY outcome
Timeframe: baseline, week 16Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.
Outcome measures
| Measure |
Placebo
n=67 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=74 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 16)
|
3.68 units on a scale
Standard Error 2.46
|
3.66 units on a scale
Standard Error 2.33
|
SECONDARY outcome
Timeframe: baseline, week 20Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.
Outcome measures
| Measure |
Placebo
n=66 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=73 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 20)
|
4.27 units on a scale
Standard Error 2.55
|
3.08 units on a scale
Standard Error 2.44
|
SECONDARY outcome
Timeframe: baseline, week 24Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.
Outcome measures
| Measure |
Placebo
n=64 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=71 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 24)
|
4.04 units on a scale
Standard Error 2.43
|
-1.84 units on a scale
Standard Error 2.29
|
SECONDARY outcome
Timeframe: baselinePopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.
Outcome measures
| Measure |
Placebo
n=74 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=89 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline)
|
19.3 units on a scale
Standard Deviation 22.17
|
22.0 units on a scale
Standard Deviation 22.06
|
SECONDARY outcome
Timeframe: baseline, week 4Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.
Outcome measures
| Measure |
Placebo
n=69 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=83 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 4)
|
-2.39 units on a scale
Standard Error 2.48
|
-3.50 units on a scale
Standard Error 2.31
|
SECONDARY outcome
Timeframe: baseline, week 8Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.
Outcome measures
| Measure |
Placebo
n=68 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=77 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 8)
|
-0.62 units on a scale
Standard Error 2.96
|
-1.04 units on a scale
Standard Error 2.86
|
SECONDARY outcome
Timeframe: baseline, week 12Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.
Outcome measures
| Measure |
Placebo
n=68 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=76 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 12)
|
0.32 units on a scale
Standard Error 2.09
|
4.11 units on a scale
Standard Error 2.02
|
SECONDARY outcome
Timeframe: baseline, week 16Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.
Outcome measures
| Measure |
Placebo
n=67 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=74 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 16)
|
2.20 units on a scale
Standard Error 2.78
|
4.79 units on a scale
Standard Error 2.64
|
SECONDARY outcome
Timeframe: baseline, week 20Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.
Outcome measures
| Measure |
Placebo
n=66 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=73 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 20)
|
3.93 units on a scale
Standard Error 2.58
|
4.10 units on a scale
Standard Error 2.50
|
SECONDARY outcome
Timeframe: baseline, week 24Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.
Outcome measures
| Measure |
Placebo
n=63 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=71 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 24)
|
2.20 units on a scale
Standard Error 2.70
|
-2.70 units on a scale
Standard Error 2.50
|
SECONDARY outcome
Timeframe: baselinePopulation: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.
Outcome measures
| Measure |
Placebo
n=76 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=94 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline)
|
5.5 units on a scale
Standard Deviation 19.31
|
2.7 units on a scale
Standard Deviation 12.35
|
SECONDARY outcome
Timeframe: baseline, week 4Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.
Outcome measures
| Measure |
Placebo
n=71 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=88 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 4)
|
-1.89 units on a scale
Standard Error 1.96
|
-0.15 units on a scale
Standard Error 1.77
|
SECONDARY outcome
Timeframe: baseline, week 8Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.
Outcome measures
| Measure |
Placebo
n=71 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=84 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 8)
|
-1.94 units on a scale
Standard Error 2.62
|
3.85 units on a scale
Standard Error 2.43
|
SECONDARY outcome
Timeframe: baseline, week 12Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.
Outcome measures
| Measure |
Placebo
n=71 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=80 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 12)
|
0.12 units on a scale
Standard Error 1.63
|
4.22 units on a scale
Standard Error 1.55
|
SECONDARY outcome
Timeframe: baseline, week 16Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.
Outcome measures
| Measure |
Placebo
n=71 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=80 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 16)
|
-3.39 units on a scale
Standard Error 1.49
|
0.04 units on a scale
Standard Error 1.40
|
SECONDARY outcome
Timeframe: baseline, week 20Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.
Outcome measures
| Measure |
Placebo
n=69 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=78 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 20)
|
0.51 units on a scale
Standard Error 1.13
|
2.00 units on a scale
Standard Error 1.08
|
SECONDARY outcome
Timeframe: baseline, week 24Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.
Outcome measures
| Measure |
Placebo
n=68 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=76 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 24)
|
0.96 units on a scale
Standard Error 2.00
|
-1.37 units on a scale
Standard Error 1.86
|
SECONDARY outcome
Timeframe: baselinePopulation: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Light intensity is less than three metabolic equivalents. Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm.
Outcome measures
| Measure |
Placebo
n=184 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=203 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day
|
6.9 ln(minutes)
Standard Deviation 0.24
|
6.8 ln(minutes)
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: baseline, week 4Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Outcome measures
| Measure |
Placebo
n=175 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=188 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day
|
0.03 ln(minutes)
Standard Error 0.01
|
0.02 ln(minutes)
Standard Error 0.01
|
SECONDARY outcome
Timeframe: baseline, week 8Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Outcome measures
| Measure |
Placebo
n=175 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=184 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day
|
0.02 ln(minutes)
Standard Error 0.01
|
0.03 ln(minutes)
Standard Error 0.01
|
SECONDARY outcome
Timeframe: baseline, week 12Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Light intensity defined as less than three metabolic equivalents. Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Outcome measures
| Measure |
Placebo
n=173 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=185 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day
|
0.03 ln(minutes)
Standard Error 0.01
|
0.02 ln(minutes)
Standard Error 0.01
|
SECONDARY outcome
Timeframe: baseline, week 16Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Outcome measures
| Measure |
Placebo
n=171 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=183 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day
|
0.03 ln(minutes)
Standard Error 0.01
|
0.04 ln(minutes)
Standard Error 0.01
|
SECONDARY outcome
Timeframe: baseline, week 20Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Outcome measures
| Measure |
Placebo
n=172 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=182 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day
|
0.03 ln(minutes)
Standard Error 0.01
|
0.04 ln(minutes)
Standard Error 0.01
|
SECONDARY outcome
Timeframe: baseline, week 24Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Outcome measures
| Measure |
Placebo
n=167 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=186 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day
|
0.02 ln(minutes)
Standard Error 0.02
|
0.03 ln(minutes)
Standard Error 0.01
|
SECONDARY outcome
Timeframe: baselinePopulation: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Outcome measures
| Measure |
Placebo
n=184 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=203 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day
|
4.2 ln(minutes)
Standard Deviation 0.96
|
4.3 ln(minutes)
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: baseline, week 4Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Outcome measures
| Measure |
Placebo
n=174 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=187 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day
|
-0.06 ln(minutes)
Standard Error 0.06
|
-0.12 ln(minutes)
Standard Error 0.05
|
SECONDARY outcome
Timeframe: baseline, week 8Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Outcome measures
| Measure |
Placebo
n=175 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=184 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day
|
0.01 ln(minutes)
Standard Error 0.05
|
-0.06 ln(minutes)
Standard Error 0.05
|
SECONDARY outcome
Timeframe: baseline, week 12Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Outcome measures
| Measure |
Placebo
n=173 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=183 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day
|
-0.14 ln(minutes)
Standard Error 0.07
|
-0.09 ln(minutes)
Standard Error 0.06
|
SECONDARY outcome
Timeframe: baseline, week 16Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Outcome measures
| Measure |
Placebo
n=171 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=183 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day
|
-0.26 ln(minutes)
Standard Error 0.07
|
-0.20 ln(minutes)
Standard Error 0.06
|
SECONDARY outcome
Timeframe: baseline, week 20Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Outcome measures
| Measure |
Placebo
n=172 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=182 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day
|
-0.20 ln(minutes)
Standard Error 0.07
|
-0.20 ln(minutes)
Standard Error 0.07
|
SECONDARY outcome
Timeframe: baseline, week 24Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Outcome measures
| Measure |
Placebo
n=167 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=186 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day
|
-0.19 ln(minutes)
Standard Error 0.08
|
-0.20 ln(minutes)
Standard Error 0.07
|
SECONDARY outcome
Timeframe: baselinePopulation: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Outcome measures
| Measure |
Placebo
n=184 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=203 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Number of Participants With Healthy Lifestyle (Baseline)
Yes
|
126 Participants
|
143 Participants
|
|
Number of Participants With Healthy Lifestyle (Baseline)
No
|
58 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: week 4Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Outcome measures
| Measure |
Placebo
n=187 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=204 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Number of Participants With Healthy Lifestyle (Week 4)
Yes
|
129 Participants
|
154 Participants
|
|
Number of Participants With Healthy Lifestyle (Week 4)
No
|
58 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: week 8Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Outcome measures
| Measure |
Placebo
n=191 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=197 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Number of Participants With Healthy Lifestyle (Week 8)
Yes
|
125 Participants
|
137 Participants
|
|
Number of Participants With Healthy Lifestyle (Week 8)
No
|
66 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: week 12Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Outcome measures
| Measure |
Placebo
n=189 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=199 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Number of Participants With Healthy Lifestyle (Week 12)
Yes
|
118 Participants
|
139 Participants
|
|
Number of Participants With Healthy Lifestyle (Week 12)
No
|
71 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: week 16Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Outcome measures
| Measure |
Placebo
n=187 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=193 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Number of Participants With Healthy Lifestyle (Week 16)
Yes
|
116 Participants
|
133 Participants
|
|
Number of Participants With Healthy Lifestyle (Week 16)
No
|
71 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: week 20Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Outcome measures
| Measure |
Placebo
n=188 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=190 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Number of Participants With Healthy Lifestyle (Week 20)
Yes
|
127 Participants
|
134 Participants
|
|
Number of Participants With Healthy Lifestyle (Week 20)
No
|
61 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: week 24Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Outcome measures
| Measure |
Placebo
n=182 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=196 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Number of Participants With Healthy Lifestyle (Week 24)
Yes
|
118 Participants
|
136 Participants
|
|
Number of Participants With Healthy Lifestyle (Week 24)
No
|
64 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: baselinePopulation: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
The amount of energy (kcal/day) that a person uses while physically active.
Outcome measures
| Measure |
Placebo
n=184 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=203 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Active Energy Expenditure (Baseline)
|
0.87 kilo calories per day
Standard Deviation 0.46
|
0.87 kilo calories per day
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: baseline, week 4Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
The amount of energy (kcal/day) that a person uses while physically active.
Outcome measures
| Measure |
Placebo
n=175 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=188 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Active Energy Expenditure (Week 4)
|
-0.04 kilo calories per day
Standard Error 0.03
|
-0.03 kilo calories per day
Standard Error 0.02
|
SECONDARY outcome
Timeframe: baseline, week 8Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
The amount of energy (kcal/day) that a person uses while physically active.
Outcome measures
| Measure |
Placebo
n=175 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=184 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Active Energy Expenditure (Week 8)
|
0.01 kilo calories per day
Standard Error 0.03
|
-0.03 kilo calories per day
Standard Error 0.03
|
SECONDARY outcome
Timeframe: baseline, week 12Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
The amount of energy (kcal/day) that a person uses while physically active.
Outcome measures
| Measure |
Placebo
n=173 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=185 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Active Energy Expenditure (Week 12)
|
-0.05 kilo calories per day
Standard Error 0.03
|
-0.06 kilo calories per day
Standard Error 0.03
|
SECONDARY outcome
Timeframe: baseline, week 16Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
The amount of energy (kcal/day) that a person uses while physically active.
Outcome measures
| Measure |
Placebo
n=171 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=183 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Active Energy Expenditure (Week 16)
|
-0.07 kilo calories per day
Standard Error 0.03
|
-0.09 kilo calories per day
Standard Error 0.03
|
SECONDARY outcome
Timeframe: baseline, week 20Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
The amount of energy (kcal/day) that a person uses while physically active.
Outcome measures
| Measure |
Placebo
n=172 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=182 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Active Energy Expenditure (Week 20)
|
-0.08 kilo calories per day
Standard Error 0.04
|
-0.09 kilo calories per day
Standard Error 0.03
|
SECONDARY outcome
Timeframe: baseline, week 24Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
The amount of energy (kcal/day) that a person uses while physically active.
Outcome measures
| Measure |
Placebo
n=167 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=186 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Active Energy Expenditure (Week 24)
|
-0.08 kilo calories per day
Standard Error 0.04
|
-0.10 kilo calories per day
Standard Error 0.04
|
SECONDARY outcome
Timeframe: baselinePopulation: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Number of steps per day (baseline)
Outcome measures
| Measure |
Placebo
n=184 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=203 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Number of Steps Per Day (Baseline)
|
7343.4 Steps
Standard Deviation 3711.8
|
7366.1 Steps
Standard Deviation 3816.0
|
SECONDARY outcome
Timeframe: baseline, week 4Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Change from baseline in number of steps per day (week 4)
Outcome measures
| Measure |
Placebo
n=175 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=188 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Number of Steps Per Day (Week 4)
|
-263.91 Steps
Standard Error 203.37
|
-287.45 Steps
Standard Error 189.24
|
SECONDARY outcome
Timeframe: baseline, week 8Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Change from baseline in number of steps per day (week 8)
Outcome measures
| Measure |
Placebo
n=175 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=184 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Number of Steps Per Day(Week 8)
|
-121.66 Steps
Standard Error 214.73
|
-153.09 Steps
Standard Error 203.84
|
SECONDARY outcome
Timeframe: baseline, week 12Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Change from baseline in Number of steps per day (week 12)
Outcome measures
| Measure |
Placebo
n=173 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=185 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Number of Steps Per Day (Week 12)
|
-351.30 Steps
Standard Error 239.39
|
-169.31 Steps
Standard Error 221.09
|
SECONDARY outcome
Timeframe: baseline, week 16Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Change from baseline in number of steps per day (week 16)
Outcome measures
| Measure |
Placebo
n=171 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=183 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Number of Steps Per Day (Week 16)
|
-655.04 Steps
Standard Error 231.90
|
-396.21 Steps
Standard Error 217.31
|
SECONDARY outcome
Timeframe: baseline, week 20Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Change from baseline in number of steps per day (week 20)
Outcome measures
| Measure |
Placebo
n=172 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=182 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Number of Steps Per Day (Week 20)
|
-408.34 Steps
Standard Error 247.32
|
-197.17 Steps
Standard Error 232.96
|
SECONDARY outcome
Timeframe: baseline, week 24Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
Change from baseline in number of steps per day (week 24)
Outcome measures
| Measure |
Placebo
n=167 Participants
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=186 Participants
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Change From Baseline in Number of Steps Per Day (Week 24)
|
-234.80 Steps
Standard Error 261.49
|
-183.34 Steps
Standard Error 232.69
|
Adverse Events
Placebo
Tiotropium
Serious adverse events
| Measure |
Placebo
n=219 participants at risk
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=238 participants at risk
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/219 • First drug administration until 30 days after last drug administration
|
0.42%
1/238 • First drug administration until 30 days after last drug administration
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/219 • First drug administration until 30 days after last drug administration
|
0.42%
1/238 • First drug administration until 30 days after last drug administration
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/219 • First drug administration until 30 days after last drug administration
|
0.42%
1/238 • First drug administration until 30 days after last drug administration
|
|
Injury, poisoning and procedural complications
Renal injury
|
0.46%
1/219 • First drug administration until 30 days after last drug administration
|
0.00%
0/238 • First drug administration until 30 days after last drug administration
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/219 • First drug administration until 30 days after last drug administration
|
0.42%
1/238 • First drug administration until 30 days after last drug administration
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/219 • First drug administration until 30 days after last drug administration
|
0.42%
1/238 • First drug administration until 30 days after last drug administration
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.00%
0/219 • First drug administration until 30 days after last drug administration
|
0.42%
1/238 • First drug administration until 30 days after last drug administration
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/219 • First drug administration until 30 days after last drug administration
|
0.42%
1/238 • First drug administration until 30 days after last drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.8%
4/219 • First drug administration until 30 days after last drug administration
|
0.42%
1/238 • First drug administration until 30 days after last drug administration
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.46%
1/219 • First drug administration until 30 days after last drug administration
|
0.00%
0/238 • First drug administration until 30 days after last drug administration
|
|
Cardiac disorders
Angina pectoris
|
0.46%
1/219 • First drug administration until 30 days after last drug administration
|
0.00%
0/238 • First drug administration until 30 days after last drug administration
|
|
Cardiac disorders
Atrial fibrillation
|
0.46%
1/219 • First drug administration until 30 days after last drug administration
|
0.00%
0/238 • First drug administration until 30 days after last drug administration
|
|
Cardiac disorders
Cardiac failure
|
0.46%
1/219 • First drug administration until 30 days after last drug administration
|
0.00%
0/238 • First drug administration until 30 days after last drug administration
|
|
Cardiac disorders
Coronary artery disease
|
0.46%
1/219 • First drug administration until 30 days after last drug administration
|
0.00%
0/238 • First drug administration until 30 days after last drug administration
|
|
Cardiac disorders
Coronary artery stenosis
|
0.46%
1/219 • First drug administration until 30 days after last drug administration
|
0.00%
0/238 • First drug administration until 30 days after last drug administration
|
|
Cardiac disorders
Myocardial ischaemia
|
0.46%
1/219 • First drug administration until 30 days after last drug administration
|
0.00%
0/238 • First drug administration until 30 days after last drug administration
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/219 • First drug administration until 30 days after last drug administration
|
0.42%
1/238 • First drug administration until 30 days after last drug administration
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.46%
1/219 • First drug administration until 30 days after last drug administration
|
0.00%
0/238 • First drug administration until 30 days after last drug administration
|
|
Gastrointestinal disorders
Rectal polyp
|
0.46%
1/219 • First drug administration until 30 days after last drug administration
|
0.00%
0/238 • First drug administration until 30 days after last drug administration
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/219 • First drug administration until 30 days after last drug administration
|
0.42%
1/238 • First drug administration until 30 days after last drug administration
|
|
Infections and infestations
Joint abscess
|
0.00%
0/219 • First drug administration until 30 days after last drug administration
|
0.42%
1/238 • First drug administration until 30 days after last drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.46%
1/219 • First drug administration until 30 days after last drug administration
|
0.00%
0/238 • First drug administration until 30 days after last drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.46%
1/219 • First drug administration until 30 days after last drug administration
|
0.00%
0/238 • First drug administration until 30 days after last drug administration
|
Other adverse events
| Measure |
Placebo
n=219 participants at risk
Placebo matching tiotropium via HandiHaler® + PRN albuterol
|
Tiotropium
n=238 participants at risk
18 mcg tiotropium via HandiHaler® + PRN albuterol
|
|---|---|---|
|
Infections and infestations
Nasophayngitis
|
5.0%
11/219 • First drug administration until 30 days after last drug administration
|
6.7%
16/238 • First drug administration until 30 days after last drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
9.6%
21/219 • First drug administration until 30 days after last drug administration
|
4.6%
11/238 • First drug administration until 30 days after last drug administration
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER