Trial Outcomes & Findings for Efficacy and Safety of 4 Weeks of Treatment With Inhaled BI 1744 CL in Patients With Asthma (NCT NCT00467740)
NCT ID: NCT00467740
Last Updated: 2014-06-27
Results Overview
Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation at the end of the dosing interval.
COMPLETED
PHASE2
296 participants
Baseline and 4 weeks
2014-06-27
Participant Flow
Participant milestones
| Measure |
Placebo
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
54
|
61
|
60
|
60
|
61
|
|
Overall Study
COMPLETED
|
53
|
58
|
58
|
59
|
61
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of 4 Weeks of Treatment With Inhaled BI 1744 CL in Patients With Asthma
Baseline characteristics by cohort
| Measure |
Placebo
n=54 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=60 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
Total
n=296 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
43.59 years
STANDARD_DEVIATION 14.11 • n=99 Participants
|
45.36 years
STANDARD_DEVIATION 15.12 • n=107 Participants
|
46.17 years
STANDARD_DEVIATION 12.96 • n=206 Participants
|
46.25 years
STANDARD_DEVIATION 14.45 • n=7 Participants
|
44.62 years
STANDARD_DEVIATION 12.95 • n=31 Participants
|
45.23 years
STANDARD_DEVIATION 13.88 • n=30 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
33 Participants
n=31 Participants
|
170 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
126 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksPopulation: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation at the end of the dosing interval.
Outcome measures
| Measure |
Placebo
n=53 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=59 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Trough FEV1 Response After 4 Weeks
|
0.004 Liter
Standard Error 0.034
|
0.083 Liter
Standard Error 0.032
|
0.090 Liter
Standard Error 0.032
|
0.080 Liter
Standard Error 0.032
|
0.150 Liter
Standard Error 0.032
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Response was defined as change from baseline. Baseline peak expiratory flow response (PEFR) was defined as the mean of the morning PEFR measurements obtained during the week just prior to first dose of randomized treatment.
Outcome measures
| Measure |
Placebo
n=54 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=60 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=59 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Weekly Mean Pre-dose Morning PEFR After 4 Weeks
|
368.18 Liter/minute
Standard Error 5.713
|
384.42 Liter/minute
Standard Error 5.377
|
396.06 Liter/minute
Standard Error 5.419
|
404.26 Liter/minute
Standard Error 5.465
|
411.13 Liter/minute
Standard Error 5.377
|
SECONDARY outcome
Timeframe: Baseline and 1 weekPopulation: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation at the end of the dosing interval.
Outcome measures
| Measure |
Placebo
n=53 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=59 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Trough FEV1 Response After 1 Week
|
-0.007 Liter
Standard Error 0.033
|
0.060 Liter
Standard Error 0.031
|
0.094 Liter
Standard Error 0.032
|
0.106 Liter
Standard Error 0.031
|
0.166 Liter
Standard Error 0.031
|
SECONDARY outcome
Timeframe: Baseline and 2 weeksPopulation: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation at the end of the dosing interval.
Outcome measures
| Measure |
Placebo
n=53 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=59 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Trough FEV1 Response After 2 Weeks
|
-0.009 Liter
Standard Error 0.036
|
0.094 Liter
Standard Error 0.034
|
0.080 Liter
Standard Error 0.034
|
0.034 Liter
Standard Error 0.034
|
0.131 Liter
Standard Error 0.034
|
SECONDARY outcome
Timeframe: Baseline and 1 weekPopulation: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation at the end of the dosing interval.
Outcome measures
| Measure |
Placebo
n=53 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=59 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Trough FVC Response After 1 Week
|
0.001 Liter
Standard Error 0.036
|
0.053 Liter
Standard Error 0.034
|
0.044 Liter
Standard Error 0.034
|
0.070 Liter
Standard Error 0.034
|
0.131 Liter
Standard Error 0.034
|
SECONDARY outcome
Timeframe: Baseline and 2 weeksPopulation: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation at the end of the dosing interval.
Outcome measures
| Measure |
Placebo
n=53 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=59 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Trough FVC Response After 2 Weeks
|
-0.029 Liter
Standard Error 0.041
|
0.098 Liter
Standard Error 0.039
|
0.069 Liter
Standard Error 0.039
|
-0.002 Liter
Standard Error 0.038
|
0.100 Liter
Standard Error 0.038
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation at the end of the dosing interval.
Outcome measures
| Measure |
Placebo
n=53 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=59 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Trough FVC Response After 4 Weeks
|
0.018 Liter
Standard Error 0.041
|
0.055 Liter
Standard Error 0.039
|
0.076 Liter
Standard Error 0.039
|
0.042 Liter
Standard Error 0.039
|
0.166 Liter
Standard Error 0.038
|
SECONDARY outcome
Timeframe: 1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h, 4h, 5h, 6h relative to dose at Week 4Population: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.
Outcome measures
| Measure |
Placebo
n=54 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=60 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-6 h (AUC 0-6h) Response at Week 4
|
0.091 Liter
Standard Error 0.037
|
0.269 Liter
Standard Error 0.035
|
0.229 Liter
Standard Error 0.035
|
0.190 Liter
Standard Error 0.035
|
0.323 Liter
Standard Error 0.035
|
SECONDARY outcome
Timeframe: 1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h, 4h, 5h, 6h relative to dose at Week 4Population: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. FVC AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.
Outcome measures
| Measure |
Placebo
n=54 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=60 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Forced Vital Capacity (FVC) Area Under Curve 0-6 h (AUC 0-6h) Response at Week 4
|
0.076 Liter
Standard Error 0.045
|
0.159 Liter
Standard Error 0.042
|
0.154 Liter
Standard Error 0.043
|
0.113 Liter
Standard Error 0.043
|
0.267 Liter
Standard Error 0.042
|
SECONDARY outcome
Timeframe: 1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Day 1Population: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
Outcome measures
| Measure |
Placebo
n=54 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=60 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Day 1
|
0.092 Liter
Standard Error 0.030
|
0.271 Liter
Standard Error 0.028
|
0.275 Liter
Standard Error 0.028
|
0.265 Liter
Standard Error 0.028
|
0.383 Liter
Standard Error 0.028
|
SECONDARY outcome
Timeframe: 1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 1Population: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
Outcome measures
| Measure |
Placebo
n=54 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=60 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 1
|
0.062 Liter
Standard Error 0.034
|
0.252 Liter
Standard Error 0.032
|
0.258 Liter
Standard Error 0.033
|
0.219 Liter
Standard Error 0.032
|
0.325 Liter
Standard Error 0.032
|
SECONDARY outcome
Timeframe: 1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 2Population: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
Outcome measures
| Measure |
Placebo
n=54 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=60 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 2
|
0.084 Liter
Standard Error 0.038
|
0.298 Liter
Standard Error 0.036
|
0.240 Liter
Standard Error 0.036
|
0.172 Liter
Standard Error 0.036
|
0.311 Liter
Standard Error 0.035
|
SECONDARY outcome
Timeframe: 1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 4Population: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
Outcome measures
| Measure |
Placebo
n=54 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=60 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 4
|
0.092 Liter
Standard Error 0.037
|
0.271 Liter
Standard Error 0.035
|
0.224 Liter
Standard Error 0.035
|
0.192 Liter
Standard Error 0.035
|
0.332 Liter
Standard Error 0.035
|
SECONDARY outcome
Timeframe: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose at day 1Population: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.
Outcome measures
| Measure |
Placebo
n=54 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=60 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Peak FEV1 (0-3h) Response At Day 1
|
0.203 Liter
Standard Error 0.036
|
0.372 Liter
Standard Error 0.034
|
0.378 Liter
Standard Error 0.034
|
0.376 Liter
Standard Error 0.034
|
0.499 Liter
Standard Error 0.034
|
SECONDARY outcome
Timeframe: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 1 weekPopulation: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.
Outcome measures
| Measure |
Placebo
n=54 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=60 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Peak FEV1 (0-3h) Response After 1 Week
|
0.170 Liter
Standard Error 0.036
|
0.343 Liter
Standard Error 0.034
|
0.355 Liter
Standard Error 0.034
|
0.308 Liter
Standard Error 0.034
|
0.407 Liter
Standard Error 0.034
|
SECONDARY outcome
Timeframe: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeksPopulation: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.
Outcome measures
| Measure |
Placebo
n=54 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=60 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Peak FEV1 (0-3h) Response After 2 Weeks
|
0.182 Liter
Standard Error 0.041
|
0.386 Liter
Standard Error 0.039
|
0.335 Liter
Standard Error 0.039
|
0.261 Liter
Standard Error 0.038
|
0.403 Liter
Standard Error 0.038
|
SECONDARY outcome
Timeframe: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 4 weeksPopulation: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.
Outcome measures
| Measure |
Placebo
n=54 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=60 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Peak FEV1 (0-3h) Response After 4 Weeks
|
0.198 Liter
Standard Error 0.040
|
0.363 Liter
Standard Error 0.038
|
0.315 Liter
Standard Error 0.038
|
0.279 Liter
Standard Error 0.038
|
0.430 Liter
Standard Error 0.038
|
SECONDARY outcome
Timeframe: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 1 weeksPopulation: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment.
Outcome measures
| Measure |
Placebo
n=54 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=60 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Peak FVC (0-3h) Response At Day 1
|
0.218 Liter
Standard Error 0.041
|
0.297 Liter
Standard Error 0.039
|
0.315 Liter
Standard Error 0.039
|
0.315 Liter
Standard Error 0.039
|
0.398 Liter
Standard Error 0.039
|
SECONDARY outcome
Timeframe: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 1 weeksPopulation: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment.
Outcome measures
| Measure |
Placebo
n=54 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=60 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Peak FVC (0-3h) Response After 1 Week
|
0.182 Liter
Standard Error 0.044
|
0.281 Liter
Standard Error 0.041
|
0.301 Liter
Standard Error 0.042
|
0.259 Liter
Standard Error 0.042
|
0.367 Liter
Standard Error 0.041
|
SECONDARY outcome
Timeframe: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeksPopulation: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment.
Outcome measures
| Measure |
Placebo
n=54 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=60 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Peak FVC (0-3h) Response After 2 Weeks
|
0.184 Liter
Standard Error 0.047
|
0.327 Liter
Standard Error 0.045
|
0.290 Liter
Standard Error 0.045
|
0.234 Liter
Standard Error 0.045
|
0.361 Liter
Standard Error 0.045
|
SECONDARY outcome
Timeframe: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 4 weeksPopulation: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment.
Outcome measures
| Measure |
Placebo
n=54 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=60 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Peak FVC (0-3h) Response After 4 Weeks
|
0.199 Liter
Standard Error 0.051
|
0.274 Liter
Standard Error 0.048
|
0.267 Liter
Standard Error 0.048
|
0.235 Liter
Standard Error 0.048
|
0.439 Liter
Standard Error 0.048
|
SECONDARY outcome
Timeframe: 1 hour (h) prior to dose on first day of randomized treatment (baseline) and 1h, 3h, 6h, 9h, 12h relative to dose at Week 4Population: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.
Outcome measures
| Measure |
Placebo
n=52 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=59 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=55 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=56 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=55 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 6-12 h (AUC 6-12h) Response at Week 4
|
0.054 Liter
Standard Error 0.051
|
0.107 Liter
Standard Error 0.048
|
0.098 Liter
Standard Error 0.049
|
0.092 Liter
Standard Error 0.049
|
0.216 Liter
Standard Error 0.049
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Response was defined as change from baseline. Baseline PEFR was defined as the mean of the evening PEFR measurements obtained during the week just prior to first dose of randomized treatment.
Outcome measures
| Measure |
Placebo
n=54 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=60 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=59 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Weekly Mean Evening PEFR After 4 Weeks
|
384.08 Liter/minute
Standard Error 5.585
|
407.05 Liter/minute
Standard Error 5.256
|
408.68 Liter/minute
Standard Error 5.297
|
420.88 Liter/minute
Standard Error 5.341
|
426.58 Liter/minute
Standard Error 5.258
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
PEFR variability represents the absolute difference between the highest morning PEFR value and the highest evening PEFR value of 1 day, divided by the arithmetic mean of these 2 PEFR values and expressed as a percent, weekly means.
Outcome measures
| Measure |
Placebo
n=54 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=60 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=59 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
PEFR Variability After 4 Weeks
|
11.694 percentage of PEFR
Standard Error 0.780
|
10.575 percentage of PEFR
Standard Error 0.736
|
9.343 percentage of PEFR
Standard Error 0.739
|
8.649 percentage of PEFR
Standard Error 0.747
|
8.756 percentage of PEFR
Standard Error 0.733
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Weekly mean number of occasions of rescue therapy used per day (prn salbutamol \[albuterol\]) as assessed by the e-Diary (e-Diary incorporated in AM2+).
Outcome measures
| Measure |
Placebo
n=54 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=60 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=59 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Weekly Mean Number of Occasions of Rescue Therapy After 4 Weeks
|
1.449 Number of Puffs
Standard Error 0.190
|
1.162 Number of Puffs
Standard Error 0.179
|
0.923 Number of Puffs
Standard Error 0.181
|
1.117 Number of Puffs
Standard Error 0.182
|
0.856 Number of Puffs
Standard Error 0.179
|
SECONDARY outcome
Timeframe: 30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h) and 3h after drug administrationPopulation: All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.
AUC0-3 represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=3
Outcome measures
| Measure |
Placebo
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=28 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=44 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Area Under Curve From 0 to 3 Hours (AUC0-3)
Olodaterol (N=0;0;0;20;44)
|
—
|
—
|
—
|
11.8 Picogram*hours/milliliter
Geometric Coefficient of Variation 35.2
|
17.8 Picogram*hours/milliliter
Geometric Coefficient of Variation 42.1
|
|
Area Under Curve From 0 to 3 Hours (AUC0-3)
Olodaterol glucuronide (N=0;0;0;28;36)
|
—
|
—
|
—
|
9.14 Picogram*hours/milliliter
Geometric Coefficient of Variation 48.6
|
20.3 Picogram*hours/milliliter
Geometric Coefficient of Variation 48.0
|
SECONDARY outcome
Timeframe: 30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h) and 3h after drug administrationPopulation: All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.
Cmax represents the maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma.
Outcome measures
| Measure |
Placebo
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=38 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=54 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=58 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Maximum Concentration (Cmax)
Olodaterol (N=0;0;21;44;58)
|
—
|
—
|
3.54 Picogram/milliliter
Geometric Coefficient of Variation 48.4
|
4.63 Picogram/milliliter
Geometric Coefficient of Variation 59.7
|
8.24 Picogram/milliliter
Geometric Coefficient of Variation 68.6
|
|
Maximum Concentration (Cmax)
Olodaterol glucuronide (N=0;0;38;54;57)
|
—
|
—
|
3.57 Picogram/milliliter
Geometric Coefficient of Variation 82.1
|
5.00 Picogram/milliliter
Geometric Coefficient of Variation 50.4
|
9.54 Picogram/milliliter
Geometric Coefficient of Variation 69.7
|
SECONDARY outcome
Timeframe: 30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h) and 3h after drug administrationPopulation: All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.
tmax represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma.
Outcome measures
| Measure |
Placebo
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=38 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=54 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=58 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Time From Dosing to the Maximum Concentration (Tmax)
Olodaterol glucuronide (N=0;0;38;54;57)
|
—
|
—
|
2.97 hours
Interval 0.117 to 3.05
|
2.97 hours
Interval 0.233 to 3.2
|
2.97 hours
Interval 0.1 to 3.22
|
|
Time From Dosing to the Maximum Concentration (Tmax)
Olodaterol (N=0;0;21;44;58)
|
—
|
—
|
0.183 hours
Interval 0.083 to 2.97
|
0.234 hours
Interval 0.083 to 2.83
|
0.267 hours
Interval 0.067 to 1.07
|
SECONDARY outcome
Timeframe: 30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administrationPopulation: All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.
AUC0-3,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=3 at steady state.
Outcome measures
| Measure |
Placebo
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=38 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=44 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=54 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Area Under Curve From 0 to 3 Hours at Steady State (AUC0-3,ss)
Olodaterol (N=0;0;0;38;53)
|
—
|
—
|
NA Picogram*hours/milliliter
Geometric Coefficient of Variation NA
No patients analyzed.
|
13.0 Picogram*hours/milliliter
Geometric Coefficient of Variation 42.7
|
25.5 Picogram*hours/milliliter
Geometric Coefficient of Variation 56.5
|
|
Area Under Curve From 0 to 3 Hours at Steady State (AUC0-3,ss)
Olodaterol glucuronide (N=0;0;38;44;54)
|
—
|
—
|
7.71 Picogram*hours/milliliter
Geometric Coefficient of Variation 62.2
|
9.04 Picogram*hours/milliliter
Geometric Coefficient of Variation 64.2
|
19.0 Picogram*hours/milliliter
Geometric Coefficient of Variation 59.4
|
SECONDARY outcome
Timeframe: 30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administrationPopulation: All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.
AUC0-6,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=6 at steady state.
Outcome measures
| Measure |
Placebo
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=21 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=32 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=50 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss)
Olodaterol (N=0;0;0;32;50)
|
—
|
—
|
NA Picogram*hours/milliliter
Geometric Coefficient of Variation NA
No patients analyzed.
|
25.3 Picogram*hours/milliliter
Geometric Coefficient of Variation 35.7
|
46.3 Picogram*hours/milliliter
Geometric Coefficient of Variation 50.3
|
|
Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss)
Olodaterol glucuronide (N=0;0;21;23;33)
|
—
|
—
|
19.2 Picogram*hours/milliliter
Geometric Coefficient of Variation 58.2
|
21.3 Picogram*hours/milliliter
Geometric Coefficient of Variation 56.4
|
37.6 Picogram*hours/milliliter
Geometric Coefficient of Variation 54.2
|
SECONDARY outcome
Timeframe: 30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administrationPopulation: All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.
AUC0-24,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=24 at steady state.
Outcome measures
| Measure |
Placebo
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=20 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=44 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Area Under Curve From 0 to 24 Hours at Steady State (AUC0-24,ss)
Olodaterol
|
—
|
—
|
—
|
83.7 Picogram*hours/milliliter
Geometric Coefficient of Variation 30.3
|
147 Picogram*hours/milliliter
Geometric Coefficient of Variation 49.5
|
|
Area Under Curve From 0 to 24 Hours at Steady State (AUC0-24,ss)
Olodaterol glucuronide
|
—
|
—
|
—
|
NA Picogram*hours/milliliter
Geometric Coefficient of Variation NA
No patients analyzed.
|
NA Picogram*hours/milliliter
Geometric Coefficient of Variation NA
No patients analyzed.
|
SECONDARY outcome
Timeframe: 30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administrationPopulation: All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.
Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma at steady state.
Outcome measures
| Measure |
Placebo
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=46 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=46 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=56 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Maximum Concentration at Steady State (Cmax,ss)
Olodaterol N=(0;0;39;45;56)
|
—
|
—
|
3.19 Picogram/milliliter
Geometric Coefficient of Variation 35.0
|
5.09 Picogram/milliliter
Geometric Coefficient of Variation 53.0
|
12.1 Picogram/milliliter
Geometric Coefficient of Variation 69.2
|
|
Maximum Concentration at Steady State (Cmax,ss)
Olodaterol glucuronide N=(0;0;46;46;54)
|
—
|
—
|
4.16 Picogram/milliliter
Geometric Coefficient of Variation 46.8
|
5.04 Picogram/milliliter
Geometric Coefficient of Variation 57.4
|
9.19 Picogram/milliliter
Geometric Coefficient of Variation 53.6
|
SECONDARY outcome
Timeframe: 30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administrationPopulation: All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.
tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma at steady state.
Outcome measures
| Measure |
Placebo
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=46 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=46 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=56 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)
Olodaterol (N=0;0;39;45;56)
|
—
|
—
|
0.333 hours
Interval 0.083 to 2.92
|
0.333 hours
Interval 0.083 to 2.93
|
0.333 hours
Interval 0.083 to 1.08
|
|
Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)
Olodaterol glucuronide (N=0;0;46;46;54)
|
—
|
—
|
3.00 hours
Interval 0.1 to 6.0
|
3.00 hours
Interval 0.917 to 6.02
|
2.97 hours
Interval 0.35 to 6.05
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.
Adequacy of asthma control was assessed using a scale of: 0=totally controlled, to 6=Severely uncontrolled.
Outcome measures
| Measure |
Placebo
n=53 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=58 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=58 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=59 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=60 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Total Score in Asthma Control Questionnaire After 4 Weeks
|
1.456 units on a scale
Standard Error 0.089
|
1.314 units on a scale
Standard Error 0.086
|
1.260 units on a scale
Standard Error 0.086
|
1.129 units on a scale
Standard Error 0.084
|
1.181 units on a scale
Standard Error 0.084
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Treated set
Clinical relevant abnormalities for vital signs, ECG and physical examination. Any new or clinically relevant worsening of baseline conditions was reported as adverse events.
Outcome measures
| Measure |
Placebo
n=54 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=60 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Clinical Relevant Abnormalities for Vital Signs, ECG and Physical Examination
Palpitations
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Clinical Relevant Abnormalities for Vital Signs, ECG and Physical Examination
Ventricular extrasystoles
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Clinical Relevant Abnormalities for Vital Signs, ECG and Physical Examination
Blood creatine phosphokinase increased
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline and 29 daysPopulation: Treated Set
Laboratory testing: Average change from baseline of potassium measured on test-days. Pre-dose value on test day 1 is the baseline value.
Outcome measures
| Measure |
Placebo
n=51 Participants
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=54 Participants
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=52 Participants
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=56 Participants
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=57 Participants
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Laboratory Testing: Average Change From Baseline of Potassium
|
0.98 mmol/L
Inter-Quartile Range NA • Interval 0.94 to 1.02
|
0.97 mmol/L
Inter-Quartile Range NA • Interval 0.93 to 1.02
|
1.00 mmol/L
Inter-Quartile Range NA • Interval 0.95 to 1.05
|
0.99 mmol/L
Inter-Quartile Range NA • Interval 0.96 to 1.03
|
0.97 mmol/L
Inter-Quartile Range NA • Interval 0.92 to 1.02
|
Adverse Events
Placebo
Olo 2 mcg qd
Olo 5 mcg qd
Olo 10 mcg qd
Olo 20 mcg qd
Serious adverse events
| Measure |
Placebo
n=54 participants at risk
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 participants at risk
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=60 participants at risk
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 participants at risk
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 participants at risk
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/54 • 4 weeks
|
0.00%
0/61 • 4 weeks
|
0.00%
0/60 • 4 weeks
|
0.00%
0/60 • 4 weeks
|
1.6%
1/61 • 4 weeks
|
|
General disorders
Chest pain
|
0.00%
0/54 • 4 weeks
|
0.00%
0/61 • 4 weeks
|
0.00%
0/60 • 4 weeks
|
0.00%
0/60 • 4 weeks
|
1.6%
1/61 • 4 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/54 • 4 weeks
|
0.00%
0/61 • 4 weeks
|
0.00%
0/60 • 4 weeks
|
1.7%
1/60 • 4 weeks
|
0.00%
0/61 • 4 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/54 • 4 weeks
|
0.00%
0/61 • 4 weeks
|
0.00%
0/60 • 4 weeks
|
0.00%
0/60 • 4 weeks
|
1.6%
1/61 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/54 • 4 weeks
|
0.00%
0/61 • 4 weeks
|
0.00%
0/60 • 4 weeks
|
0.00%
0/60 • 4 weeks
|
1.6%
1/61 • 4 weeks
|
Other adverse events
| Measure |
Placebo
n=54 participants at risk
Matching Placebo delivered by the Respimat Inhaler.
|
Olo 2 mcg qd
n=61 participants at risk
Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 5 mcg qd
n=60 participants at risk
Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 10 mcg qd
n=60 participants at risk
Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
|
Olo 20 mcg qd
n=61 participants at risk
Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.4%
4/54 • 4 weeks
|
6.6%
4/61 • 4 weeks
|
8.3%
5/60 • 4 weeks
|
5.0%
3/60 • 4 weeks
|
3.3%
2/61 • 4 weeks
|
|
Nervous system disorders
Headache
|
5.6%
3/54 • 4 weeks
|
6.6%
4/61 • 4 weeks
|
6.7%
4/60 • 4 weeks
|
5.0%
3/60 • 4 weeks
|
8.2%
5/61 • 4 weeks
|
|
Nervous system disorders
Tremor
|
0.00%
0/54 • 4 weeks
|
0.00%
0/61 • 4 weeks
|
0.00%
0/60 • 4 weeks
|
0.00%
0/60 • 4 weeks
|
8.2%
5/61 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
7.4%
4/54 • 4 weeks
|
3.3%
2/61 • 4 weeks
|
3.3%
2/60 • 4 weeks
|
1.7%
1/60 • 4 weeks
|
3.3%
2/61 • 4 weeks
|
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
- Publication restrictions are in place
Restriction type: OTHER