Trial Outcomes & Findings for Dose Ranging Study of Indacaterol in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00403845)
NCT ID: NCT00403845
Last Updated: 2011-08-17
Results Overview
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 22, 23, and 24 hours post-dose on Day 2. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included patient, period, and treatment group as fixed effects and baseline FEV1 prior to drug administration in the treatment period as a covariate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
From 22 to 24 hours post-dose on Day 2
Results posted on
2011-08-17
Participant Flow
Participant milestones
| Measure |
Placebo-indacaterol 150μg-indacaterol 300μg-indacaterol 600μg
In treatment period, 1 patients received 2 placebo capsules; in treatment period 2, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; in treatment period 3, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; and in treatment period 4, patients received 2 indacaterol 300 μg capsules. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 150μg-indacaterol 600μg-placebo-indacaterol 300μg
In treatment period 1, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; in treatment period 2, patients received 2 indacaterol 300 μg capsules; in treatment period 3, patients received 2 placebo capsules; and in treatment period 4, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 300μg-placebo-indacaterol 600μg-indacaterol 150μg
In treatment period 1, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 2, patients received 2 placebo capsules; in treatment period 3, patients received 2 indacaterol 300 μg capsules; and in treatment period 4, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 600μg-indacaterol 300μg-indacaterol 150μg-placebo
In treatment period 1, patients received 2 indacaterol 300 μg capsules; in treatment period 2, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 3, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; and in treatment period 4 patients received 2 placebo capsules. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
12
|
13
|
11
|
14
|
|
Treatment Period 1
COMPLETED
|
11
|
13
|
11
|
13
|
|
Treatment Period 1
NOT COMPLETED
|
1
|
0
|
0
|
1
|
|
Treatment Period 2
STARTED
|
11
|
13
|
11
|
13
|
|
Treatment Period 2
COMPLETED
|
10
|
13
|
11
|
13
|
|
Treatment Period 2
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Treatment Period 3
STARTED
|
10
|
13
|
11
|
13
|
|
Treatment Period 3
COMPLETED
|
10
|
13
|
11
|
11
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
2
|
|
Treatment Period 4
STARTED
|
10
|
13
|
11
|
11
|
|
Treatment Period 4
COMPLETED
|
10
|
13
|
11
|
11
|
|
Treatment Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo-indacaterol 150μg-indacaterol 300μg-indacaterol 600μg
In treatment period, 1 patients received 2 placebo capsules; in treatment period 2, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; in treatment period 3, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; and in treatment period 4, patients received 2 indacaterol 300 μg capsules. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 150μg-indacaterol 600μg-placebo-indacaterol 300μg
In treatment period 1, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; in treatment period 2, patients received 2 indacaterol 300 μg capsules; in treatment period 3, patients received 2 placebo capsules; and in treatment period 4, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 300μg-placebo-indacaterol 600μg-indacaterol 150μg
In treatment period 1, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 2, patients received 2 placebo capsules; in treatment period 3, patients received 2 indacaterol 300 μg capsules; and in treatment period 4, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 600μg-indacaterol 300μg-indacaterol 150μg-placebo
In treatment period 1, patients received 2 indacaterol 300 μg capsules; in treatment period 2, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 3, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; and in treatment period 4 patients received 2 placebo capsules. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Treatment Period 1
Subject withdrew consent
|
1
|
0
|
0
|
0
|
|
Treatment Period 1
Subject no longer needs study drug
|
0
|
0
|
0
|
1
|
|
Treatment Period 2
Subject withdrew consent
|
1
|
0
|
0
|
0
|
|
Treatment Period 3
Subject withdrew consent
|
0
|
0
|
0
|
1
|
|
Treatment Period 3
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Dose Ranging Study of Indacaterol in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=50 Participants
The entire study population included all 4 treatment groups who received indacaterol 150 µg, 300 µg, and 600 µg and placebo via a single dose dry powder inhaler (SDDPI) in 4 different sequences. Two capsules of study medication were inhaled in the morning between 8:00 and 10:00 am on Day 1 of each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
|---|---|
|
Age Continuous
|
67.2 years
STANDARD_DEVIATION 5.94 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From 22 to 24 hours post-dose on Day 2Population: Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were included in the analysis if they had at least 1 FEV1 value at 22, 23, or 24 hours post-dose, and the data were not collected within 6 hours after the use of rescue medication.
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 22, 23, and 24 hours post-dose on Day 2. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included patient, period, and treatment group as fixed effects and baseline FEV1 prior to drug administration in the treatment period as a covariate.
Outcome measures
| Measure |
Indacaterol 600 μg
n=47 Participants
Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 300 µg
n=47 Participants
One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 150 µg
n=47 Participants
One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Placebo
n=46 Participants
Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 22 to 24 Hours Post-dose on Day 2
|
1.49 Liters
Standard Error 0.010
|
1.48 Liters
Standard Error 0.010
|
1.45 Liters
Standard Error 0.010
|
1.33 Liters
Standard Error 0.010
|
SECONDARY outcome
Timeframe: From 5 minutes to 4 hours post-dose on Day 1Population: Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, and 4 hours post-dose on Day 1. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.
Outcome measures
| Measure |
Indacaterol 600 μg
n=48 Participants
Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 300 µg
n=47 Participants
One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 150 µg
n=48 Participants
One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Placebo
n=47 Participants
Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1
|
1.58 Liters
Standard Error 0.009
|
1.57 Liters
Standard Error 0.009
|
1.54 Liters
Standard Error 0.009
|
1.42 Liters
Standard Error 0.009
|
SECONDARY outcome
Timeframe: From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2Population: Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, 4, 8, and 12 hours on Day 1 and 22, 23, and 24 hours on Day 2. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.
Outcome measures
| Measure |
Indacaterol 600 μg
n=48 Participants
Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 300 µg
n=47 Participants
One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 150 µg
n=48 Participants
One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Placebo
n=47 Participants
Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2
5 minutes
|
1.47 Liters
Interval 1.45 to 1.48
|
1.48 Liters
Interval 1.46 to 1.49
|
1.46 Liters
Interval 1.45 to 1.48
|
1.36 Liters
Interval 1.34 to 1.37
|
|
Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2
15 minutes
|
1.50 Liters
Interval 1.49 to 1.52
|
1.50 Liters
Interval 1.48 to 1.51
|
1.49 Liters
Interval 1.47 to 1.5
|
1.36 Liters
Interval 1.34 to 1.37
|
|
Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2
30 minutes
|
1.52 Liters
Interval 1.5 to 1.54
|
1.52 Liters
Interval 1.5 to 1.54
|
1.49 Liters
Interval 1.47 to 1.51
|
1.35 Liters
Interval 1.33 to 1.37
|
|
Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2
1 hour
|
1.51 Liters
Interval 1.49 to 1.53
|
1.51 Liters
Interval 1.49 to 1.53
|
1.49 Liters
Interval 1.47 to 1.51
|
1.36 Liters
Interval 1.34 to 1.38
|
|
Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2
2 hours
|
1.55 Liters
Interval 1.53 to 1.57
|
1.54 Liters
Interval 1.52 to 1.56
|
1.51 Liters
Interval 1.49 to 1.53
|
1.36 Liters
Interval 1.34 to 1.38
|
|
Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2
4 hours
|
1.53 Liters
Interval 1.5 to 1.55
|
1.53 Liters
Interval 1.5 to 1.55
|
1.48 Liters
Interval 1.46 to 1.5
|
1.35 Liters
Interval 1.33 to 1.37
|
|
Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2
8 hour
|
1.50 Liters
Interval 1.48 to 1.52
|
1.51 Liters
Interval 1.49 to 1.53
|
1.46 Liters
Interval 1.44 to 1.48
|
1.30 Liters
Interval 1.28 to 1.33
|
|
Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2
12 hours
|
1.49 Liters
Interval 1.47 to 1.51
|
1.47 Liters
Interval 1.45 to 1.49
|
1.44 Liters
Interval 1.42 to 1.46
|
1.30 Liters
Interval 1.28 to 1.32
|
|
Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2
22 hours
|
1.47 Liters
Interval 1.45 to 1.49
|
1.46 Liters
Interval 1.44 to 1.47
|
1.43 Liters
Interval 1.41 to 1.45
|
1.29 Liters
Interval 1.28 to 1.31
|
|
Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2
23 hours
|
1.51 Liters
Interval 1.49 to 1.53
|
1.49 Liters
Interval 1.47 to 1.51
|
1.46 Liters
Interval 1.44 to 1.48
|
1.33 Liters
Interval 1.32 to 1.35
|
|
Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2
24 hours
|
1.51 Liters
Interval 1.49 to 1.52
|
1.50 Liters
Interval 1.49 to 1.52
|
1.47 Liters
Interval 1.45 to 1.49
|
1.35 Liters
Interval 1.33 to 1.36
|
SECONDARY outcome
Timeframe: From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2Population: Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were included in the analysis if they had at least 1 FEV1 value at 22, 23, or 24 hours post-dose, and the data were not collected within 6 hours after the use of rescue medication.
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, 4, 8, and 12 hours on Day 1 and 22, 23, and 24 hours on Day 2. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.
Outcome measures
| Measure |
Indacaterol 600 μg
n=47 Participants
Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 300 µg
n=46 Participants
One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 150 µg
n=47 Participants
One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Placebo
n=45 Participants
Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2
|
1.50 Liters
Standard Error 0.009
|
1.49 Liters
Standard Error 0.009
|
1.46 Liters
Standard Error 0.009
|
1.32 Liters
Standard Error 0.009
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Indacaterol 150 μg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Indacaterol 300 μg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Indacaterol 600 μg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=47 participants at risk
Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 150 μg
n=48 participants at risk
One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 300 μg
n=47 participants at risk
One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 600 μg
n=48 participants at risk
Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
SUBILEUS
|
0.00%
0/47
|
2.1%
1/48
|
0.00%
0/47
|
0.00%
0/48
|
Other adverse events
| Measure |
Placebo
n=47 participants at risk
Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 150 μg
n=48 participants at risk
One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 300 μg
n=47 participants at risk
One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 600 μg
n=48 participants at risk
Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
2.1%
1/47
|
8.3%
4/48
|
8.5%
4/47
|
10.4%
5/48
|
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 (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER