Trial Outcomes & Findings for Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Salts in Patients With Asthma (NCT NCT00927901)
NCT ID: NCT00927901
Last Updated: 2013-09-09
Results Overview
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Baseline and at the end of each treatment period. The analysis included period baseline FEV1 as covariate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Baseline to the end of each treatment period (Day 7)
Results posted on
2013-09-09
Participant Flow
Participant milestones
| Measure |
Indacaterol (Ind) Maleate-placebo-ind Xinafoate-ind Acetate
In treatment period 1, patients received indacaterol maleate 400 μg; in treatment period 2, patients received placebo to indacaterol; in treatment period 3, patients received indacaterol xinafoate 400 μg; and in treatment period 4, patients received indacaterol acetate 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol (Ind) Xinafoate-ind Maleate-ind Acetate-placebo
In treatment period 1, patients received indacaterol xinafoate 400 μg; in treatment period 2, patients received indacaterol maleate 400 μg; in treatment period 3, patients received indacaterol acetate 400 μg; and in treatment period 4, patients received placebo to indacaterol 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol (Ind) Acetate-ind Xinafoate-placebo-ind Maleate
In treatment period 1, patients received indacaterol acetate 400 μg; in treatment period 2, patients received indacaterol xinafoate 400 μg; in treatment period 3, patients received placebo to indacaterol; and in treatment period 4, patients received indacaterol maleate 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Placebo-indacaterol (Ind) Acetate-ind Maleate-ind Xinafoate
In treatment period 1, patients received placebo to indacaterol; in treatment period 2, patients received indacaterol acetate 400 μg; in treatment period 3, patients received indacaterol maleate 400 μg; and in treatment period 4, patients received indacaterol xinafoate 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
7
|
7
|
7
|
9
|
|
Treatment Period 1
COMPLETED
|
7
|
7
|
6
|
9
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Treatment Period 2
STARTED
|
7
|
7
|
6
|
9
|
|
Treatment Period 2
COMPLETED
|
7
|
7
|
6
|
9
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 3
STARTED
|
7
|
7
|
6
|
9
|
|
Treatment Period 3
COMPLETED
|
7
|
7
|
6
|
9
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 4
STARTED
|
7
|
7
|
6
|
9
|
|
Treatment Period 4
COMPLETED
|
7
|
7
|
5
|
8
|
|
Treatment Period 4
NOT COMPLETED
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Indacaterol (Ind) Maleate-placebo-ind Xinafoate-ind Acetate
In treatment period 1, patients received indacaterol maleate 400 μg; in treatment period 2, patients received placebo to indacaterol; in treatment period 3, patients received indacaterol xinafoate 400 μg; and in treatment period 4, patients received indacaterol acetate 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol (Ind) Xinafoate-ind Maleate-ind Acetate-placebo
In treatment period 1, patients received indacaterol xinafoate 400 μg; in treatment period 2, patients received indacaterol maleate 400 μg; in treatment period 3, patients received indacaterol acetate 400 μg; and in treatment period 4, patients received placebo to indacaterol 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol (Ind) Acetate-ind Xinafoate-placebo-ind Maleate
In treatment period 1, patients received indacaterol acetate 400 μg; in treatment period 2, patients received indacaterol xinafoate 400 μg; in treatment period 3, patients received placebo to indacaterol; and in treatment period 4, patients received indacaterol maleate 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Placebo-indacaterol (Ind) Acetate-ind Maleate-ind Xinafoate
In treatment period 1, patients received placebo to indacaterol; in treatment period 2, patients received indacaterol acetate 400 μg; in treatment period 3, patients received indacaterol maleate 400 μg; and in treatment period 4, patients received indacaterol xinafoate 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Treatment Period 1
Subject withdrew consent
|
0
|
0
|
1
|
0
|
|
Treatment Period 4
Adverse Event
|
0
|
0
|
0
|
1
|
|
Treatment Period 4
Subject withdrew consent
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Salts in Patients With Asthma
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=30 Participants
The entire study population included all 4 treatment groups who received the 3 salt forms of indacaterol 400 µg (maleate, acetate, and xinafoate) and placebo to indacaterol in 4 different sequences. The dose refers to 400 μg of free base indacaterol. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|
|
Age Continuous
|
50 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to the end of each treatment period (Day 7)Population: Efficacy analysis set: All randomized subjects that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Baseline and at the end of each treatment period. The analysis included period baseline FEV1 as covariate.
Outcome measures
| Measure |
Indacaterol Maleate 400 μg
n=28 Participants
Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol Acetate 400 μg
n=29 Participants
Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol Xinafoate 400 μg
n=28 Participants
Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Placebo to Indacaterol
n=29 Participants
Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 7)
|
0.186 Liters
Interval 0.1079 to 0.2649
|
0.190 Liters
Interval 0.1133 to 0.2673
|
0.194 Liters
Interval 0.1164 to 0.2728
|
-0.021 Liters
Interval -0.0982 to 0.0558
|
SECONDARY outcome
Timeframe: Baseline to Day 1Population: Efficacy analysis set: All randomized subjects that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Baseline and on Day 1. The analysis included period baseline FEV1 as covariate.
Outcome measures
| Measure |
Indacaterol Maleate 400 μg
n=29 Participants
Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol Acetate 400 μg
n=30 Participants
Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol Xinafoate 400 μg
n=29 Participants
Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Placebo to Indacaterol
n=29 Participants
Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 1
|
0.161 Liters
Interval 0.0877 to 0.2344
|
0.185 Liters
Interval 0.1129 to 0.2572
|
0.205 Liters
Interval 0.1325 to 0.2792
|
0.008 Liters
Interval -0.0649 to 0.0819
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: Efficacy analysis set: All randomized subjects that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.
FEV1 was measured with spirometry conducted according to internationally accepted standards at 5, 15, and 30 minutes; 1 hour, 1 hour 30 minutes; and 2, 4, and 12 hours post-dose on Day 1 and Day 7.
Outcome measures
| Measure |
Indacaterol Maleate 400 μg
n=29 Participants
Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol Acetate 400 μg
n=30 Participants
Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol Xinafoate 400 μg
n=29 Participants
Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Placebo to Indacaterol
n=29 Participants
Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 7
Day 1, N=29, 30, 29, 29
|
4.00 Hours
Interval 3.0 to 6.125
|
2.13 Hours
Interval 1.5 to 3.0
|
1.50 Hours
Interval 1.04 to 2.5
|
2.25 Hours
Interval 1.5 to 12.085
|
|
Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 7
Day 7, N=28, 29, 28, 29
|
3.00 Hours
Interval 2.0 to 4.0
|
2.50 Hours
Interval 1.5 to 4.0
|
3.00 Hours
Interval 1.25 to 12.0
|
12.38 Hours
Interval 11.71 to 13.875
|
SECONDARY outcome
Timeframe: Baseline to the end of each treatment period (Day 7)Population: Efficacy analysis set: All randomized subjects that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.
Patients recorded use of rescue medication (salbutamol/albuterol multi-dose inhaler) as the number of puffs taken in respective preceding 12 hours morning and evening in a diary. Patient with any use of rescue medication (any number of puffs \> 0) was included to calculate endpoint.
Outcome measures
| Measure |
Indacaterol Maleate 400 μg
n=29 Participants
Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol Acetate 400 μg
n=30 Participants
Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol Xinafoate 400 μg
n=29 Participants
Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Placebo to Indacaterol
n=29 Participants
Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Percentage of Patients Using Rescue Medication During Each 7 Day Treatment Period
|
21 Percentage of participants
|
10 Percentage of participants
|
17 Percentage of participants
|
21 Percentage of participants
|
SECONDARY outcome
Timeframe: End of each treatment period (Day 7)Population: Pharmacokinetic analysis set: All subjects with evaluable pharmacokinetic parameter data. Number of subjects varied due to missing values.
Venous blood samples for pharmacokinetic evaluation were collected at 15 and 30 minutes; and 1, 2, 4, 12, and 24 hours post-dose at the end of each 7 day treatment period and were analyzed using a LC-MS/MS assay. Area under the concentration-time curve up to 24 hours (AUC\[0-24 hours\]) was calculated from concentration-time data and recorded sampling times using non-compartmental methods.
Outcome measures
| Measure |
Indacaterol Maleate 400 μg
n=29 Participants
Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol Acetate 400 μg
n=28 Participants
Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol Xinafoate 400 μg
n=27 Participants
Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Placebo to Indacaterol
Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Indacaterol Exposure (AUC[0-24 Hours]) at the End of Each 7 Day Treatment Period
|
5159 pg * hr/mL
Geometric Coefficient of Variation 27.9 • Interval 3003.0 to 10893.0
|
5434 pg * hr/mL
Geometric Coefficient of Variation 30.7 • Interval 3581.0 to 13634.0
|
5170 pg * hr/mL
Geometric Coefficient of Variation 24.2 • Interval 3312.0 to 8349.0
|
—
|
SECONDARY outcome
Timeframe: End of each treatment period (Day 7)Population: Pharmacokinetic analysis set: All subjects with evaluable pharmacokinetic parameter data. Number of subjects varied due to missing values.
Venous blood samples for pharmacokinetic evaluation were collected at 15 and 30 minutes; and 1, 2, 4, 12, and 24 hours post-dose at the end of each 7 day treatment period and were analyzed using a LC-MS/MS assay. Maximum (peak) plasma drug concentration after drug administration (Cmax) was calculated from concentration-time data and recorded sampling times using non-compartmental methods.
Outcome measures
| Measure |
Indacaterol Maleate 400 μg
n=28 Participants
Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol Acetate 400 μg
n=28 Participants
Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol Xinafoate 400 μg
n=28 Participants
Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Placebo to Indacaterol
Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Indacaterol Exposure (Cmax) at the End of Each 7 Day Treatment Period
|
720 pg/mL
Geometric Coefficient of Variation 35.5 • Interval 338.0 to 1550.0
|
753 pg/mL
Geometric Coefficient of Variation 40.6 • Interval 322.0 to 1870.0
|
664 pg/mL
Geometric Coefficient of Variation 26.4 • Interval 397.0 to 1150.0
|
—
|
Adverse Events
Indacaterol Acetate 400 μg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Indacaterol Maleate 400 μg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Indacaterol Xinafoate 400 μg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo to Indacaterol
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Indacaterol Acetate 400 μg
n=30 participants at risk
Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol Maleate 400 μg
n=29 participants at risk
Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol Xinafoate 400 μg
n=29 participants at risk
Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Placebo to Indacaterol
n=29 participants at risk
Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/30 • Baseline to the end of the study (approximately 11 weeks)
Safety population: All subjects who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline to the end of the study (approximately 11 weeks)
Safety population: All subjects who received at least 1 dose of study drug.
|
13.8%
4/29 • Baseline to the end of the study (approximately 11 weeks)
Safety population: All subjects who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline to the end of the study (approximately 11 weeks)
Safety population: All subjects who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
3.3%
1/30 • Baseline to the end of the study (approximately 11 weeks)
Safety population: All subjects who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline to the end of the study (approximately 11 weeks)
Safety population: All subjects who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline to the end of the study (approximately 11 weeks)
Safety population: All subjects who received at least 1 dose of study drug.
|
13.8%
4/29 • Baseline to the end of the study (approximately 11 weeks)
Safety population: All subjects who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
4/30 • Baseline to the end of the study (approximately 11 weeks)
Safety population: All subjects who received at least 1 dose of study drug.
|
10.3%
3/29 • Baseline to the end of the study (approximately 11 weeks)
Safety population: All subjects who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline to the end of the study (approximately 11 weeks)
Safety population: All subjects who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline to the end of the study (approximately 11 weeks)
Safety population: All subjects who received at least 1 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