Trial Outcomes & Findings for Dose Ranging Study for Indacaterol in Japanese Asthma Patients (NCT NCT00403754)
NCT ID: NCT00403754
Last Updated: 2011-08-17
Results Overview
Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC22-24h) of FEV1 values taken at 22, 23 and 24 hours post dose, was calculated based on the trapezoidal rule. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
22, 23, and 24 hours post-dose on Day 2
Results posted on
2011-08-17
Participant Flow
A 14 day eligibility screening period insured all participants were stable on their permissible asthma treatment before proceeding onto core study drug treatment.
Participant milestones
| Measure |
Placebo-Ind 150 μg-Ind 300 μg-Ind 600 μg-Salmeterol
In treatment period 1: patients received 2 placebo capsules; in treatment period 2: patients received 1 indacaterol (Ind) 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. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Ind 150 μg-Ind 600 μg-Placebo-Ind 300 μg-Salmeterol
In treatment period 1: patients received 1 indacaterol (Ind) 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. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Ind 300 μg-Placebo-Ind 600 μg-Ind 150 μg-Salmeterol
In treatment period 1: patients received 1 indacaterol (Ind) 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. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation, device on Day 1.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use t
|
Ind 600 μg-Ind 300 μg-Ind150 μg-Placebo-Salmeterol
In treatment period 1: patients received 2 indacaterol (Ind) 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. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use t
|
|---|---|---|---|---|
|
Core Treatment Period 1
STARTED
|
11
|
10
|
9
|
11
|
|
Core Treatment Period 1
COMPLETED
|
11
|
9
|
9
|
11
|
|
Core Treatment Period 1
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Core Treatment Period 2
STARTED
|
11
|
9
|
9
|
11
|
|
Core Treatment Period 2
COMPLETED
|
11
|
9
|
8
|
11
|
|
Core Treatment Period 2
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Core Treatment Period 3
STARTED
|
11
|
9
|
8
|
11
|
|
Core Treatment Period 3
COMPLETED
|
11
|
9
|
8
|
11
|
|
Core Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Core Treatment Period 4
STARTED
|
11
|
9
|
8
|
11
|
|
Core Treatment Period 4
COMPLETED
|
11
|
9
|
8
|
11
|
|
Core Treatment Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Open Label: Salmeterol
STARTED
|
11
|
9
|
8
|
11
|
|
Open Label: Salmeterol
COMPLETED
|
11
|
9
|
8
|
11
|
|
Open Label: Salmeterol
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo-Ind 150 μg-Ind 300 μg-Ind 600 μg-Salmeterol
In treatment period 1: patients received 2 placebo capsules; in treatment period 2: patients received 1 indacaterol (Ind) 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. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Ind 150 μg-Ind 600 μg-Placebo-Ind 300 μg-Salmeterol
In treatment period 1: patients received 1 indacaterol (Ind) 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. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Ind 300 μg-Placebo-Ind 600 μg-Ind 150 μg-Salmeterol
In treatment period 1: patients received 1 indacaterol (Ind) 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. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation, device on Day 1.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use t
|
Ind 600 μg-Ind 300 μg-Ind150 μg-Placebo-Salmeterol
In treatment period 1: patients received 2 indacaterol (Ind) 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. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use t
|
|---|---|---|---|---|
|
Core Treatment Period 1
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Core Treatment Period 2
Lack of Efficacy
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Dose Ranging Study for Indacaterol in Japanese Asthma Patients
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=41 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 the 4 different sequences of the core phase. Two capsules of study medication were inhaled in the morning on Day 1 of each treatment period. Following the core phase patients continued to the Salmeterol open label phase. Salmeterol was inhaled via a Diskus inhalation device 50 µg in the morning and 50 µg 12 hours post initial dose on Day 1. Patients received each treatment only once.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
|---|---|
|
Age Continuous
|
47.8 years
STANDARD_DEVIATION 14.90 • n=93 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 22, 23, and 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.
Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC22-24h) of FEV1 values taken at 22, 23 and 24 hours post dose, was calculated based on the trapezoidal rule. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.
Outcome measures
| Measure |
Indacaterol 600 µg
n=39 Participants
Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Indacaterol 300 µg
n=40 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 on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Indacaterol 150 µg
n=40 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 on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Placebo
n=40 Participants
Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Salmeterol 100 μg
n=39 Participants
Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) 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
|
2.31 Liters
Standard Error 0.023
|
2.28 Liters
Standard Error 0.022
|
2.24 Liters
Standard Error 0.022
|
2.06 Liters
Standard Error 0.022
|
2.23 Liters
Standard Error 0.022
|
SECONDARY outcome
Timeframe: 5, 15, and 30 minutes; and 1, 2, 4, 8, and 12 hours post-dose on Day 1; and 22, 23, and 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.
Spirometry was conducted according to internationally accepted standards. FEV1 by time point was calculated using a mixed model with (period) baseline, defined as the value measured prior to the first study drug intake in the period, as a covariate.
Outcome measures
| Measure |
Indacaterol 600 µg
n=39 Participants
Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Indacaterol 300 µg
n=40 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 on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Indacaterol 150 µg
n=40 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 on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Placebo
n=40 Participants
Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Salmeterol 100 μg
n=39 Participants
Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) 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
24 hours
|
2.32 Liters
Interval 2.28 to 2.35
|
2.29 Liters
Interval 2.25 to 2.33
|
2.26 Liters
Interval 2.22 to 2.3
|
2.09 Liters
Interval 2.06 to 2.13
|
2.27 Liters
Interval 2.23 to 2.31
|
|
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
5 minutes
|
2.25 Liters
Interval 2.22 to 2.27
|
2.20 Liters
Interval 2.18 to 2.23
|
2.19 Liters
Interval 2.16 to 2.22
|
2.04 Liters
Interval 2.01 to 2.07
|
2.13 Liters
Interval 2.1 to 2.15
|
|
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
|
2.33 Liters
Interval 2.3 to 2.36
|
2.28 Liters
Interval 2.25 to 2.32
|
2.27 Liters
Interval 2.24 to 2.3
|
2.05 Liters
Interval 2.02 to 2.08
|
2.19 Liters
Interval 2.16 to 2.22
|
|
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
|
2.37 Liters
Interval 2.34 to 2.41
|
2.33 Liters
Interval 2.3 to 2.37
|
2.30 Liters
Interval 2.27 to 2.34
|
2.07 Liters
Interval 2.03 to 2.1
|
2.24 Liters
Interval 2.21 to 2.27
|
|
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
|
2.41 Liters
Interval 2.38 to 2.45
|
2.35 Liters
Interval 2.32 to 2.38
|
2.32 Liters
Interval 2.29 to 2.35
|
2.09 Liters
Interval 2.06 to 2.12
|
2.29 Liters
Interval 2.25 to 2.32
|
|
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
2 hours
|
2.45 Liters
Interval 2.41 to 2.48
|
2.39 Liters
Interval 2.35 to 2.43
|
2.38 Liters
Interval 2.34 to 2.42
|
2.13 Liters
Interval 2.09 to 2.16
|
2.34 Liters
Interval 2.3 to 2.37
|
|
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
4 hours
|
2.42 Liters
Interval 2.38 to 2.47
|
2.39 Liters
Interval 2.35 to 2.43
|
2.35 Liters
Interval 2.31 to 2.39
|
2.10 Liters
Interval 2.06 to 2.14
|
2.34 Liters
Interval 2.3 to 2.38
|
|
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
8 hours
|
2.37 Liters
Interval 2.33 to 2.41
|
2.35 Liters
Interval 2.31 to 2.38
|
2.28 Liters
Interval 2.24 to 2.31
|
2.06 Liters
Interval 2.02 to 2.09
|
2.25 Liters
Interval 2.21 to 2.29
|
|
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
|
2.33 Liters
Interval 2.28 to 2.37
|
2.30 Liters
Interval 2.26 to 2.34
|
2.24 Liters
Interval 2.2 to 2.28
|
2.00 Liters
Interval 1.96 to 2.05
|
2.20 Liters
Interval 2.16 to 2.24
|
|
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
|
2.30 Liters
Interval 2.26 to 2.34
|
2.25 Liters
Interval 2.21 to 2.29
|
2.20 Liters
Interval 2.16 to 2.24
|
2.01 Liters
Interval 1.97 to 2.05
|
2.18 Liters
Interval 2.14 to 2.22
|
|
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
|
2.32 Liters
Interval 2.28 to 2.36
|
2.28 Liters
Interval 2.25 to 2.32
|
2.25 Liters
Interval 2.21 to 2.29
|
2.06 Liters
Interval 2.02 to 2.1
|
2.23 Liters
Interval 2.2 to 2.27
|
SECONDARY outcome
Timeframe: 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.
Spirometry was conducted according to internationally accepted standards. Peak FEV1 is the maximum FEV1 recorded in the period between 5 minutes and 4 hours post dose. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.
Outcome measures
| Measure |
Indacaterol 600 µg
n=39 Participants
Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Indacaterol 300 µg
n=40 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 on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Indacaterol 150 µg
n=40 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 on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Placebo
n=40 Participants
Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Salmeterol 100 μg
n=39 Participants
Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) 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
|
2.49 Liters
Standard Error 0.018
|
2.44 Liters
Standard Error 0.018
|
2.41 Liters
Standard Error 0.018
|
2.19 Liters
Standard Error 0.18
|
2.39 Liters
Standard Error 0.018
|
SECONDARY outcome
Timeframe: 5 minutes to 12 hours post-dose on Day 1; and 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.
Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC0-24h) of FEV1 values taken at pre-dose to 24 hours post dose was calculated based on the trapezoidal rule. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.
Outcome measures
| Measure |
Indacaterol 600 µg
n=39 Participants
Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Indacaterol 300 µg
n=40 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 on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Indacaterol 150 µg
n=40 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 on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Placebo
n=40 Participants
Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Salmeterol 100 μg
n=39 Participants
Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) 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 Post-dose on Day 1 to 24 Hours Post-dose on Day 2
|
2.35 Liters
Standard Error 0.022
|
2.31 Liters
Standard Error 0.021
|
2.26 Liters
Standard Error 0.021
|
2.04 Liters
Standard Error 0.021
|
2.24 Liters
Standard Error 0.021
|
Adverse Events
Indacaterol 150 μg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Indacaterol 300 μg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Indacaterol 600 μg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Salmeterol 100 μg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Indacaterol 150 μg
n=40 participants at risk
1 Indacaterol 150 μg capsule + 1 Placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Indacaterol 150 μg treatment period.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Indacaterol 300 μg
n=40 participants at risk
1 Indacaterol 300 μg capsules + 1 Placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Indacaterol 300 μg treatment period.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Indacaterol 600 μg
n=39 participants at risk
2 Indacaterol 300 μg capsules were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Indacaterol 600 μg treatment period.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Placebo
n=40 participants at risk
2 Placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Placebo treatment period.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
Salmeterol 100 μg
n=39 participants at risk
Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
|
|---|---|---|---|---|---|
|
Nervous system disorders
HEADACHE
|
5.0%
2/40
Safety Population included all participants who received at least one dose of study drug.
|
5.0%
2/40
Safety Population included all participants who received at least one dose of study drug.
|
2.6%
1/39
Safety Population included all participants who received at least one dose of study drug.
|
7.5%
3/40
Safety Population included all participants who received at least one dose of study drug.
|
2.6%
1/39
Safety Population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
35.0%
14/40
Safety Population included all participants who received at least one dose of study drug.
|
32.5%
13/40
Safety Population included all participants who received at least one dose of study drug.
|
35.9%
14/39
Safety Population included all participants who received at least one dose of study drug.
|
7.5%
3/40
Safety Population included all participants who received at least one dose of study drug.
|
0.00%
0/39
Safety Population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
OBSTRUCTIVE AIRWAYS DISORDER
|
2.5%
1/40
Safety Population included all participants who received at least one dose of study drug.
|
2.5%
1/40
Safety Population included all participants who received at least one dose of study drug.
|
5.1%
2/39
Safety Population included all participants who received at least one dose of study drug.
|
0.00%
0/40
Safety Population included all participants who received at least one dose of study drug.
|
0.00%
0/39
Safety Population included all participants who received at least one dose of study drug.
|
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