Trial Outcomes & Findings for Crossover Study to Evaluate the Efficacy, Safety and Tolerability of Different Doses of Indacaterol in Patients With Persistent Asthma (NCT NCT01959412)
NCT ID: NCT01959412
Last Updated: 2015-05-06
Results Overview
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured pre-dose and over a 24 hours post-dose period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
91 participants
Primary outcome timeframe
Day 1 (24 hours)
Results posted on
2015-05-06
Participant Flow
Participant milestones
| Measure |
Sequence 4 (Ind 150 μg)
indacaterol 150 μg, indacaterol 27.5 μg, indacaterol 75 μg, placebo indacaterol 55 μg indacaterol 37.5 μg Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
|
Sequence 3 (Ind 75 μg)
indacaterol 75 μg indacaterol 150 μg indacaterol 55 μg indacaterol 27.5 μg indacaterol 37.5 μg placebo Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
|
Sequence 2 (Ind 55 μg)
indacaterol 55 μg indacaterol 75 μg indacaterol 37.5 μg indacaterol 150 μg placebo indacaterol 27.5 μg Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
|
Sequence 1 (Ind 37.5 μg)
indacaterol 37.5 μg indacaterol 55μg Placebo indacaterol 75μg indacaterol 27.5μg indacaterol 150μg indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
|
Sequence 5 (Ind 27.5 μg)
indacaterol 27.5 μg placebo indacaterol 150 μg indacaterol 37.5 μg indacaterol 75 μg indacaterol 55 μg Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
|
Sequence 6 (Placebo)
Placebo, indacaterol 37.5 μg, indacaterol 27.5 μg indacaterol 55 μg, indacaterol 150 μg, indacaterol 75 μg Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
15
|
16
|
15
|
|
Overall Study
COMPLETED
|
14
|
14
|
15
|
13
|
13
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
2
|
3
|
0
|
Reasons for withdrawal
| Measure |
Sequence 4 (Ind 150 μg)
indacaterol 150 μg, indacaterol 27.5 μg, indacaterol 75 μg, placebo indacaterol 55 μg indacaterol 37.5 μg Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
|
Sequence 3 (Ind 75 μg)
indacaterol 75 μg indacaterol 150 μg indacaterol 55 μg indacaterol 27.5 μg indacaterol 37.5 μg placebo Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
|
Sequence 2 (Ind 55 μg)
indacaterol 55 μg indacaterol 75 μg indacaterol 37.5 μg indacaterol 150 μg placebo indacaterol 27.5 μg Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
|
Sequence 1 (Ind 37.5 μg)
indacaterol 37.5 μg indacaterol 55μg Placebo indacaterol 75μg indacaterol 27.5μg indacaterol 150μg indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
|
Sequence 5 (Ind 27.5 μg)
indacaterol 27.5 μg placebo indacaterol 150 μg indacaterol 37.5 μg indacaterol 75 μg indacaterol 55 μg Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
|
Sequence 6 (Placebo)
Placebo, indacaterol 37.5 μg, indacaterol 27.5 μg indacaterol 55 μg, indacaterol 150 μg, indacaterol 75 μg Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
|
|---|---|---|---|---|---|---|
|
Overall Study
Protocol deviation
|
1
|
1
|
0
|
1
|
3
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Crossover Study to Evaluate the Efficacy, Safety and Tolerability of Different Doses of Indacaterol in Patients With Persistent Asthma
Baseline characteristics by cohort
| Measure |
All Participants
n=91 Participants
All participants randomized to one of six treatment sequences
|
|---|---|
|
Age, Continuous
|
47.4 Years
STANDARD_DEVIATION 13.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 (24 hours)Population: drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured pre-dose and over a 24 hours post-dose period.
Outcome measures
| Measure |
Ind 37.5 μg
n=84 Participants
Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
|
Ind 27.5
n=87 Participants
Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
|
Placebo
n=86 Participants
Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
|
Ind 150 μg
n=84 Participants
Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
|
Ind 75 μg
n=86 Participants
Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
|
Ind 55 μg
n=85 Participants
Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
|
|---|---|---|---|---|---|---|
|
Change From Period Baseline in FEV1 (L) AUC(0-24h)
|
0.121 Liters
Standard Error 0.0153
|
0.143 Liters
Standard Error 0.0151
|
0.022 Liters
Standard Error 0.0152
|
0.209 Liters
Standard Error 0.0153
|
0.165 Liters
Standard Error 0.0152
|
0.154 Liters
Standard Error 0.0152
|
SECONDARY outcome
Timeframe: Day 1 (12 hours)Population: The Full Analysis Set (FAS) consisted of all patients in the RAN who received at least 1 dose of study drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured pre-dose and over a 12 hours post-dose period.
Outcome measures
| Measure |
Ind 37.5 μg
n=84 Participants
Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
|
Ind 27.5
n=87 Participants
Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
|
Placebo
n=86 Participants
Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
|
Ind 150 μg
n=84 Participants
Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
|
Ind 75 μg
n=86 Participants
Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
|
Ind 55 μg
n=85 Participants
Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
|
|---|---|---|---|---|---|---|
|
Change From Period Baseline in FEV1 (L) AUC(0-12h) and FEV1 (L) AUC(12- 24h)
FEV1 AUC (0-12h)
|
0.131 liters
Standard Error 0.0150
|
0.125 liters
Standard Error 0.0148
|
0.036 liters
Standard Error 0.0148
|
0.229 liters
Standard Error 0.0150
|
0.180 liters
Standard Error 0.0148
|
0.176 liters
Standard Error 0.0149
|
|
Change From Period Baseline in FEV1 (L) AUC(0-12h) and FEV1 (L) AUC(12- 24h)
FEV1 AUC (12-24h)
|
0.115 liters
Standard Error 0.0177
|
0.164 liters
Standard Error 0.0175
|
0.012 liters
Standard Error 0.0175
|
0.190 liters
Standard Error 0.0177
|
0.153 liters
Standard Error 0.0175
|
0.136 liters
Standard Error 0.0176
|
SECONDARY outcome
Timeframe: Day 1 (24 hours)Population: The Full Analysis Set (FAS) consisted of all patients in the RAN who received at least 1 dose of study drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables
Spirometry will be conducted according to internationally accepted standards. Peak Forced Expiratory Volume in 1 second (FEV1) is the maximum FEV1 recorded between different time points.
Outcome measures
| Measure |
Ind 37.5 μg
n=84 Participants
Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
|
Ind 27.5
n=87 Participants
Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
|
Placebo
n=86 Participants
Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
|
Ind 150 μg
n=84 Participants
Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
|
Ind 75 μg
n=86 Participants
Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
|
Ind 55 μg
n=85 Participants
Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
|
|---|---|---|---|---|---|---|
|
Change From Period Baseline in Peak FEV1 (L)
|
0.249 Liters
Standard Error 0.0154
|
0.259 Liters
Standard Error 0.0152
|
0.158 Liters
Standard Error 0.0152
|
0.347 Liters
Standard Error 0.0154
|
0.290 Liters
Standard Error 0.0152
|
0.298 Liters
Standard Error 0.0153
|
SECONDARY outcome
Timeframe: Day 1 (24 hours)Population: The Full Analysis Set (FAS) consisted of all patients in the RAN who received at least 1 dose of study drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 is defined as the mean of two measurements at different time points.
Outcome measures
| Measure |
Ind 37.5 μg
n=83 Participants
Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
|
Ind 27.5
n=86 Participants
Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
|
Placebo
n=86 Participants
Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
|
Ind 150 μg
n=82 Participants
Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
|
Ind 75 μg
n=86 Participants
Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
|
Ind 55 μg
n=84 Participants
Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
|
|---|---|---|---|---|---|---|
|
Change From Period Baseline in Trough FEV1 (L)
|
0.128 Liters
Standard Error 0.0182
|
0.161 Liters
Standard Error 0.0180
|
0.024 Liters
Standard Error 0.0180
|
0.207 Liters
Standard Error 0.0183
|
0.162 Liters
Standard Error 0.0180
|
0.137 Liters
Standard Error 0.0181
|
SECONDARY outcome
Timeframe: Day 1 (24 hours)Population: The Full Analysis Set (FAS) consisted of all patients in the RAN who received at least 1 dose of study drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables
Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.
Outcome measures
| Measure |
Ind 37.5 μg
n=84 Participants
Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
|
Ind 27.5
n=87 Participants
Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
|
Placebo
n=86 Participants
Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
|
Ind 150 μg
n=84 Participants
Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
|
Ind 75 μg
n=86 Participants
Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
|
Ind 55 μg
n=85 Participants
Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
|
|---|---|---|---|---|---|---|
|
Change From Period Baseline in FVC (L) AUC (0-24h)
|
0.085 Liters
Standard Error 0.0183
|
0.106 Liters
Standard Error 0.0180
|
0.016 Liters
Standard Error 0.0181
|
0.147 Liters
Standard Error 0.0183
|
0.120 Liters
Standard Error 0.0181
|
0.118 Liters
Standard Error 0.0182
|
Adverse Events
Ind 150 μg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Ind 75 μg
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Ind 55 μg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Ind 37.5 μg
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Ind 27.5
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ind 150 μg
n=88 participants at risk
Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
|
Ind 75 μg
n=87 participants at risk
Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
|
Ind 55 μg
n=86 participants at risk
Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
|
Ind 37.5 μg
n=85 participants at risk
Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
|
Ind 27.5
n=90 participants at risk
Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
|
Placebo
n=88 participants at risk
Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/88
|
0.00%
0/87
|
0.00%
0/86
|
1.2%
1/85
|
0.00%
0/90
|
0.00%
0/88
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/88
|
1.1%
1/87
|
0.00%
0/86
|
0.00%
0/85
|
0.00%
0/90
|
0.00%
0/88
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/88
|
0.00%
0/87
|
1.2%
1/86
|
0.00%
0/85
|
0.00%
0/90
|
0.00%
0/88
|
Other adverse events
| Measure |
Ind 150 μg
n=88 participants at risk
Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
|
Ind 75 μg
n=87 participants at risk
Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
|
Ind 55 μg
n=86 participants at risk
Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
|
Ind 37.5 μg
n=85 participants at risk
Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
|
Ind 27.5
n=90 participants at risk
Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
|
Placebo
n=88 participants at risk
Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/88
|
0.00%
0/87
|
2.3%
2/86
|
0.00%
0/85
|
0.00%
0/90
|
0.00%
0/88
|
|
Infections and infestations
NASOPHARYNGITIS
|
2.3%
2/88
|
3.4%
3/87
|
0.00%
0/86
|
0.00%
0/85
|
0.00%
0/90
|
2.3%
2/88
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/88
|
1.1%
1/87
|
1.2%
1/86
|
1.2%
1/85
|
2.2%
2/90
|
2.3%
2/88
|
|
Injury, poisoning and procedural complications
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION
|
5.7%
5/88
|
2.3%
2/87
|
2.3%
2/86
|
2.4%
2/85
|
4.4%
4/90
|
3.4%
3/88
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
9.1%
8/88
|
9.2%
8/87
|
5.8%
5/86
|
9.4%
8/85
|
6.7%
6/90
|
2.3%
2/88
|
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 or disclosure of trial results in their entirety
- Publication restrictions are in place
Restriction type: OTHER