Trial Outcomes & Findings for Effect of Indacaterol on Inspiratory Capacity (IC) (NCT NCT01012765)
NCT ID: NCT01012765
Last Updated: 2016-02-17
Results Overview
IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean over the 3 values which were measured each at 30min, 2 hour, 3 hour and 4 hour post dose by body plethysmography. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
173 participants
Primary outcome timeframe
21 days
Results posted on
2016-02-17
Participant Flow
173 participants were screened. 129 participants entered the study.
Participant milestones
| Measure |
Tiotropium - Placebo - Indacaterol
In treatment period 1, patients received tiotropium 18µg twice daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Indacaterol - Placebo - Tiotropium
In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received tiotropium 18µg twice daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Indacaterol - Tiotropium - Placebo
In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received tiotropium 18µg twice daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Placebo - Indacaterol - Tiotropium
In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received tiotropium 18µg twice daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Placebo - Tiotropium - Indacaterol
In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received tiotropium 18µg twice daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Tiotropium - Indacaterol - Placebo
In treatment period 1, patients received tiotropium 18µg twice daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
20
|
21
|
23
|
18
|
22
|
25
|
|
Treatment Period 1
COMPLETED
|
17
|
21
|
21
|
15
|
19
|
25
|
|
Treatment Period 1
NOT COMPLETED
|
3
|
0
|
2
|
3
|
3
|
0
|
|
Treatment Period 2
STARTED
|
17
|
21
|
21
|
15
|
19
|
25
|
|
Treatment Period 2
COMPLETED
|
16
|
19
|
18
|
15
|
18
|
24
|
|
Treatment Period 2
NOT COMPLETED
|
1
|
2
|
3
|
0
|
1
|
1
|
|
Treatment Period 3
STARTED
|
16
|
19
|
18
|
15
|
18
|
24
|
|
Treatment Period 3
COMPLETED
|
16
|
19
|
18
|
15
|
18
|
24
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Tiotropium - Placebo - Indacaterol
In treatment period 1, patients received tiotropium 18µg twice daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Indacaterol - Placebo - Tiotropium
In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received tiotropium 18µg twice daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Indacaterol - Tiotropium - Placebo
In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received tiotropium 18µg twice daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Placebo - Indacaterol - Tiotropium
In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received tiotropium 18µg twice daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Placebo - Tiotropium - Indacaterol
In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received tiotropium 18µg twice daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Tiotropium - Indacaterol - Placebo
In treatment period 1, patients received tiotropium 18µg twice daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
Adverse Event
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period 1
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 1
Administrative problems
|
0
|
0
|
1
|
1
|
1
|
0
|
|
Treatment Period 1
Protocol Violation
|
0
|
0
|
0
|
2
|
1
|
0
|
|
Treatment Period 1
Unsatisfactory therapeutic effect
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period 2
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
1
|
0
|
|
Treatment Period 2
Abnormal laboratory value(s)
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period 2
Adverse Event
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Treatment Period 2
Unsatisfactory therapeutic effect
|
0
|
1
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Effect of Indacaterol on Inspiratory Capacity (IC)
Baseline characteristics by cohort
| Measure |
Safety Set
n=129 Participants
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
|---|---|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 8.9 • n=39 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 21 days were included in the analysis.
IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean over the 3 values which were measured each at 30min, 2 hour, 3 hour and 4 hour post dose by body plethysmography. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
Outcome measures
| Measure |
Indacaterol
n=110 Participants
Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Placebo
n=106 Participants
Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Tiotropium
n=105 Participants
Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
|---|---|---|---|
|
Peak Inspiratory Capacity (IC) After 21 Days of Treatment
|
2.69 Liters
Interval 2.64 to 2.75
|
2.48 Liters
Interval 2.42 to 2.53
|
2.63 Liters
Interval 2.58 to 2.69
|
SECONDARY outcome
Timeframe: 20 daysPopulation: Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 20 days were included in this analysis.
Trough IC was measured with spirometry conducted according to internationally accepted standards. Trough IC was calculated as the mean of the three measurements of pre-dose body plethysmography (days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
Outcome measures
| Measure |
Indacaterol
n=87 Participants
Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Placebo
n=83 Participants
Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Tiotropium
n=84 Participants
Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
|---|---|---|---|
|
Trough IC After 20 Days of Treatment
|
2.43 Liters
Interval 2.37 to 2.5
|
2.28 Liters
Interval 2.21 to 2.34
|
2.39 Liters
Interval 2.32 to 2.45
|
SECONDARY outcome
Timeframe: 21 daysPopulation: Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 21 days were included in this analysis.
Peak RV was measured with spirometry conducted according to internationally accepted standards. Peak RV was calculated as the Total Lung Capacity minus the maximum of the three Inspiratory Vital Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
Outcome measures
| Measure |
Indacaterol
n=85 Participants
Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Placebo
n=82 Participants
Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Tiotropium
n=84 Participants
Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
|---|---|---|---|
|
Peak Residual Volume (RV) After 21 Days of Treatment
|
3.77 Liters
Interval 3.67 to 3.87
|
4.17 Liters
Interval 4.07 to 4.27
|
3.79 Liters
Interval 3.69 to 3.89
|
SECONDARY outcome
Timeframe: 21 daysPopulation: Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 21 days were included in this analysis.
TLC was measured with spirometry conducted according to internationally accepted standards. Peak TLC was calculated as the mean of the three Functional Residual Capacity peak measurements plus the mean of the three Inspiratory Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
Outcome measures
| Measure |
Indacaterol
n=86 Participants
Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Placebo
n=82 Participants
Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Tiotropium
n=84 Participants
Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
|---|---|---|---|
|
Peak Total Lung Capacity (TLC) After 21 Days of Treatment
|
7.25 Liters
Interval 7.16 to 7.33
|
7.38 Liters
Interval 7.3 to 7.47
|
7.25 Liters
Interval 7.16 to 7.33
|
SECONDARY outcome
Timeframe: 21 daysPopulation: Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 21 days were included in this analysis.
Peak RV/TLC ratio was measured with spirometry conducted according to internationally accepted standards. Peak RV/TLC was defined as the peak RV/peak TLC. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
Outcome measures
| Measure |
Indacaterol
n=83 Participants
Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Placebo
n=81 Participants
Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Tiotropium
n=84 Participants
Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
|---|---|---|---|
|
Peak Residual Volume/Peak Total Lung Capacity (RV/TLC) Ratio After 21 Days of Treatment
|
0.52 Ratio
Interval 0.51 to 0.53
|
0.57 Ratio
Interval 0.56 to 0.58
|
0.53 Ratio
Interval 0.52 to 0.53
|
SECONDARY outcome
Timeframe: 21 daysPopulation: Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 21 days were included in the analysis.
Peak sRaw was measured with spirometry conducted according to internationally accepted standards. Peak sRaw was the mean of the three measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
Outcome measures
| Measure |
Indacaterol
n=101 Participants
Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Placebo
n=97 Participants
Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Tiotropium
n=99 Participants
Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
|---|---|---|---|
|
Peak Specific Airway Resistance (sRaw) After 21 Days of Treatment
|
2.05 kPa*sec
Interval 1.89 to 2.22
|
3.08 kPa*sec
Interval 2.91 to 3.24
|
2.00 kPa*sec
Interval 1.83 to 2.16
|
SECONDARY outcome
Timeframe: 21 daysPopulation: Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 21 days were included in the analysis.
FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was measured 30 minutes post-dose. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
Outcome measures
| Measure |
Indacaterol
n=108 Participants
Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Placebo
n=106 Participants
Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Tiotropium
n=109 Participants
Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
|---|---|---|---|
|
FEV1 30 Minutes Post-dose After 21 Days of Treatment
|
1.92 Liters
Interval 1.89 to 1.96
|
1.68 Liters
Interval 1.64 to 1.71
|
1.91 Liters
Interval 1.88 to 1.95
|
SECONDARY outcome
Timeframe: 20 daysPopulation: Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 20 days were included in the analysis.
FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was measured pre-dose after 20 days of treatment. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
Outcome measures
| Measure |
Indacaterol
n=111 Participants
Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Placebo
n=110 Participants
Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Tiotropium
n=112 Participants
Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
|---|---|---|---|
|
Trough Forced Expiratory Volume in 1 Second (FEV1) After 20 Days of Treatment
|
1.80 Liters
Interval 1.77 to 1.84
|
1.61 Liters
Interval 1.57 to 1.64
|
1.78 Liters
Interval 1.75 to 1.82
|
Adverse Events
Indacaterol 150ug
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Tiotropium 18ug
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Indacaterol 150ug
n=118 participants at risk
Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Placebo
n=120 participants at risk
Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Tiotropium 18ug
n=119 participants at risk
Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
|---|---|---|---|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/118
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
0.00%
0/120
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
0.84%
1/119
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.85%
1/118
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
0.00%
0/120
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
0.00%
0/119
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
|
Injury, poisoning and procedural complications
INJURY
|
0.00%
0/118
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
0.00%
0/120
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
0.84%
1/119
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.00%
0/118
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
0.83%
1/120
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
0.84%
1/119
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
Other adverse events
| Measure |
Indacaterol 150ug
n=118 participants at risk
Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Placebo
n=120 participants at risk
Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
Tiotropium 18ug
n=119 participants at risk
Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
|
|---|---|---|---|
|
Infections and infestations
NASOPHARYNGITIS
|
7.6%
9/118
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
6.7%
8/120
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
2.5%
3/119
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
|
Infections and infestations
RHINITIS
|
1.7%
2/118
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
0.00%
0/120
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
0.00%
0/119
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
1.7%
2/118
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
1.7%
2/120
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
4.2%
5/119
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
|
Nervous system disorders
HEADACHE
|
1.7%
2/118
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
2.5%
3/120
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
1.7%
2/119
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
3.4%
4/118
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
0.00%
0/120
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
0.00%
0/119
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
2.5%
3/118
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
1.7%
2/120
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
0.84%
1/119
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/118
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
1.7%
2/120
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
0.00%
0/119
The safety set included all participants who received at least one dose of study medication during at least one study period.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER