Trial Outcomes & Findings for A Crossover Study to Determine the 24 Hour Lung Function Profile of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00622635)
NCT ID: NCT00622635
Last Updated: 2011-08-18
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 the end of each treatment period. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
68 participants
Primary outcome timeframe
After 14 days
Results posted on
2011-08-18
Participant Flow
Participant milestones
| Measure |
Indacaterol 300 μg - Placebo to Indacaterol - Salmeterol 50 μg
In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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 - Salmeterol 50 μg - Indacaterol 300 μg
In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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.
|
Salmeterol 50 μg - Indacaterol 300 μg - Placebo to Indacaterol
In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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 - Indacaterol 300 μg - Salmeterol 50 μg
In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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 300 μg - Salmeterol 50 μg - Placebo to Indacaterol
In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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.
|
Salmeterol 50 μg - Placebo to Indacaterol - Indacaterol 300 μg
In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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
|
13
|
11
|
11
|
13
|
10
|
10
|
|
Treatment Period 1
COMPLETED
|
13
|
10
|
10
|
13
|
9
|
10
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
1
|
1
|
0
|
1
|
0
|
|
Treatment Period 2
STARTED
|
13
|
10
|
10
|
13
|
9
|
10
|
|
Treatment Period 2
COMPLETED
|
12
|
10
|
10
|
13
|
9
|
10
|
|
Treatment Period 2
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 3
STARTED
|
12
|
10
|
10
|
13
|
9
|
10
|
|
Treatment Period 3
COMPLETED
|
12
|
10
|
10
|
10
|
9
|
10
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Indacaterol 300 μg - Placebo to Indacaterol - Salmeterol 50 μg
In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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 - Salmeterol 50 μg - Indacaterol 300 μg
In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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.
|
Salmeterol 50 μg - Indacaterol 300 μg - Placebo to Indacaterol
In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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 - Indacaterol 300 μg - Salmeterol 50 μg
In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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 300 μg - Salmeterol 50 μg - Placebo to Indacaterol
In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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.
|
Salmeterol 50 μg - Placebo to Indacaterol - Indacaterol 300 μg
In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period 1
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period 1
Abnormal test procedure result(s)
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period 2
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 3
Adverse Event
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Treatment Period 3
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Crossover Study to Determine the 24 Hour Lung Function Profile of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=68 Participants
The entire study population included all 6 treatment groups who received indacaterol 300 µg once daily, placebo to indacaterol once daily, and salmeterol 50 µg twice daily via a single-dose (indacaterol and placebo to indacaterol) or multi-dose (salmeterol) dry-powder inhaler in 6 different sequences. Patients received each treatment for 14 days with a 14 day washout between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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
|
65.6 years
STANDARD_DEVIATION 9.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 14 daysPopulation: 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. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of each treatment period. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.
Outcome measures
| Measure |
Indacaterol 300 μg
n=61 Participants
Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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=61 Participants
Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
Salmeterol 50 μg
n=59 Participants
Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. 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.
|
|---|---|---|---|
|
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 15)
|
1.46 Liters
Standard Error 0.027
|
1.26 Liters
Standard Error 0.027
|
1.37 Liters
Standard Error 0.027
|
SECONDARY outcome
Timeframe: 5 minutes post-dose at the end of each treatment period (Day 14)Population: 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. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.
Outcome measures
| Measure |
Indacaterol 300 μg
n=63 Participants
Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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=64 Participants
Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
Salmeterol 50 μg
n=60 Participants
Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. 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.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) 5 Minutes Post-dose at the End of Each Treatment Period (Day 14)
|
1.44 Liters
Standard Error 0.022
|
1.24 Liters
Standard Error 0.022
|
1.36 Liters
Standard Error 0.022
|
SECONDARY outcome
Timeframe: 15 minutes post-dose at the end of each treatment period (Day 14)Population: 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. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.
Outcome measures
| Measure |
Indacaterol 300 μg
n=64 Participants
Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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=64 Participants
Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
Salmeterol 50 μg
n=59 Participants
Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. 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.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) 15 Minutes Post-dose at the End of Each Treatment Period (Day 14)
|
1.47 Liters
Standard Error 0.023
|
1.27 Liters
Standard Error 0.023
|
1.41 Liters
Standard Error 0.024
|
SECONDARY outcome
Timeframe: 30 minutes post-dose at the end of each treatment period (Day 14)Population: 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. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.
Outcome measures
| Measure |
Indacaterol 300 μg
n=64 Participants
Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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=64 Participants
Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
Salmeterol 50 μg
n=60 Participants
Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. 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.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) 30 Minutes Post-dose at the End of Each Treatment Period (Day 14)
|
1.49 Liters
Standard Error 0.023
|
1.26 Liters
Standard Error 0.023
|
1.42 Liters
Standard Error 0.024
|
SECONDARY outcome
Timeframe: 1 hour post-dose at the end of each treatment period (Day 14)Population: 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. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.
Outcome measures
| Measure |
Indacaterol 300 μg
n=64 Participants
Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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=64 Participants
Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
Salmeterol 50 μg
n=60 Participants
Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. 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.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) 1 Hour Post-dose at the End of Each Treatment Period (Day 14)
|
1.49 Liters
Standard Error 0.023
|
1.26 Liters
Standard Error 0.023
|
1.42 Liters
Standard Error 0.023
|
SECONDARY outcome
Timeframe: 2 hours post-dose at the end of each treatment period (Day 14)Population: 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. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.
Outcome measures
| Measure |
Indacaterol 300 μg
n=64 Participants
Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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=62 Participants
Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
Salmeterol 50 μg
n=60 Participants
Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. 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.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) 2 Hours Post-dose at the End of Each Treatment Period (Day 14)
|
1.50 Liters
Standard Error 0.024
|
1.27 Liters
Standard Error 0.024
|
1.44 Liters
Standard Error 0.025
|
SECONDARY outcome
Timeframe: 3 hours post-dose at the end of each treatment period (Day 14)Population: 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. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.
Outcome measures
| Measure |
Indacaterol 300 μg
n=64 Participants
Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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=61 Participants
Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
Salmeterol 50 μg
n=60 Participants
Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. 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.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) 3 Hours Post-dose at the End of Each Treatment Period (Day 14)
|
1.51 Liters
Standard Error 0.023
|
1.29 Liters
Standard Error 0.024
|
1.45 Liters
Standard Error 0.024
|
SECONDARY outcome
Timeframe: 4 hours post-dose at the end of each treatment period (Day 14)Population: 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. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.
Outcome measures
| Measure |
Indacaterol 300 μg
n=63 Participants
Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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=60 Participants
Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
Salmeterol 50 μg
n=59 Participants
Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. 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.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) 4 Hours Post-dose at the End of Each Treatment Period (Day 14)
|
1.49 Liters
Standard Error 0.023
|
1.29 Liters
Standard Error 0.023
|
1.44 Liters
Standard Error 0.023
|
SECONDARY outcome
Timeframe: 5 hours post-dose at the end of each treatment period (Day 14)Population: 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. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.
Outcome measures
| Measure |
Indacaterol 300 μg
n=63 Participants
Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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=59 Participants
Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
Salmeterol 50 μg
n=59 Participants
Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. 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.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) 5 Hours Post-dose at the End of Each Treatment Period (Day 14)
|
1.49 Liters
Standard Error 0.025
|
1.26 Liters
Standard Error 0.026
|
1.45 Liters
Standard Error 0.026
|
SECONDARY outcome
Timeframe: 6 hours post-dose at the end of each treatment period (Day 14)Population: 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. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.
Outcome measures
| Measure |
Indacaterol 300 μg
n=63 Participants
Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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=57 Participants
Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
Salmeterol 50 μg
n=59 Participants
Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. 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.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) 6 Hours Post-dose at the End of Each Treatment Period (Day 14)
|
1.48 Liters
Standard Error 0.025
|
1.29 Liters
Standard Error 0.026
|
1.42 Liters
Standard Error 0.025
|
SECONDARY outcome
Timeframe: 8 hours post-dose at the end of each treatment period (Day 14)Population: 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. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.
Outcome measures
| Measure |
Indacaterol 300 μg
n=63 Participants
Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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=56 Participants
Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
Salmeterol 50 μg
n=59 Participants
Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. 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.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) 8 Hours Post-dose at the End of Each Treatment Period (Day 14)
|
1.44 Liters
Standard Error 0.025
|
1.27 Liters
Standard Error 0.026
|
1.40 Liters
Standard Error 0.026
|
SECONDARY outcome
Timeframe: 10 hours post-dose at the end of each treatment period (Day 14)Population: 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. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.
Outcome measures
| Measure |
Indacaterol 300 μg
n=63 Participants
Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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=56 Participants
Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
Salmeterol 50 μg
n=58 Participants
Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. 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.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) 10 Hours Post-dose at the End of Each Treatment Period (Day 14)
|
1.43 Liters
Standard Error 0.024
|
1.25 Liters
Standard Error 0.026
|
1.36 Liters
Standard Error 0.025
|
SECONDARY outcome
Timeframe: 11 hours 10 minutes post-dose at the end of each treatment period (Day 14)Population: 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. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.
Outcome measures
| Measure |
Indacaterol 300 μg
n=63 Participants
Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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=55 Participants
Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
Salmeterol 50 μg
n=57 Participants
Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. 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.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 14)
|
1.45 Liters
Standard Error 0.025
|
1.25 Liters
Standard Error 0.027
|
1.35 Liters
Standard Error 0.027
|
SECONDARY outcome
Timeframe: 11 hours 45 minutes post-dose at the end of each treatment period (Day 14)Population: 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. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.
Outcome measures
| Measure |
Indacaterol 300 μg
n=63 Participants
Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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=54 Participants
Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
Salmeterol 50 μg
n=57 Participants
Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. 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.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 14)
|
1.46 Liters
Standard Error 0.026
|
1.24 Liters
Standard Error 0.028
|
1.35 Liters
Standard Error 0.027
|
SECONDARY outcome
Timeframe: 14 hours post-dose at the end of each treatment period (Day 14)Population: 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. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.
Outcome measures
| Measure |
Indacaterol 300 μg
n=61 Participants
Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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=55 Participants
Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
Salmeterol 50 μg
n=58 Participants
Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. 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.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) 14 Hours Post-dose at the End of Each Treatment Period (Day 14)
|
1.45 Liters
Standard Error 0.026
|
1.24 Liters
Standard Error 0.027
|
1.39 Liters
Standard Error 0.026
|
SECONDARY outcome
Timeframe: 20 hours 10 minutes post-dose at the end of each treatment period (Day 15)Population: 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. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.
Outcome measures
| Measure |
Indacaterol 300 μg
n=60 Participants
Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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=57 Participants
Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
Salmeterol 50 μg
n=61 Participants
Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. 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.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15)
|
1.36 Liters
Standard Error 0.027
|
1.17 Liters
Standard Error 0.028
|
1.31 Liters
Standard Error 0.027
|
SECONDARY outcome
Timeframe: 20 hours 45 minutes post-dose at the end of each treatment period (Day 15)Population: 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. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.
Outcome measures
| Measure |
Indacaterol 300 μg
n=62 Participants
Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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=59 Participants
Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
Salmeterol 50 μg
n=59 Participants
Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. 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.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15)
|
1.40 Liters
Standard Error 0.025
|
1.19 Liters
Standard Error 0.026
|
1.35 Liters
Standard Error 0.026
|
SECONDARY outcome
Timeframe: 22 hours post-dose at the end of each treatment period (Day 15)Population: 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. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.
Outcome measures
| Measure |
Indacaterol 300 μg
n=62 Participants
Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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=60 Participants
Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
Salmeterol 50 μg
n=59 Participants
Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. 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.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) 22 Hours Post-dose at the End of Each Treatment Period (Day 15)
|
1.43 Liters
Standard Error 0.026
|
1.25 Liters
Standard Error 0.026
|
1.38 Liters
Standard Error 0.026
|
SECONDARY outcome
Timeframe: 23 hours 10 minutes post-dose at the end of each treatment period (Day 15)Population: 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. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.
Outcome measures
| Measure |
Indacaterol 300 μg
n=61 Participants
Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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=61 Participants
Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
Salmeterol 50 μg
n=59 Participants
Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. 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.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15)
|
1.48 Liters
Standard Error 0.030
|
1.24 Liters
Standard Error 0.030
|
1.37 Liters
Standard Error 0.031
|
SECONDARY outcome
Timeframe: 23 hours 45 minutes post-dose at the end of each treatment period (Day 15)Population: 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. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.
Outcome measures
| Measure |
Indacaterol 300 μg
n=61 Participants
Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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=61 Participants
Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
Salmeterol 50 μg
n=59 Participants
Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. 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.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15)
|
1.45 Liters
Standard Error 0.026
|
1.28 Liters
Standard Error 0.026
|
1.38 Liters
Standard Error 0.026
|
Adverse Events
Indacaterol 300 μg
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Salmeterol 50 μg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo to Indacaterol
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Indacaterol 300 μg
n=66 participants at risk
Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
Salmeterol 50 μg
n=65 participants at risk
Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. 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=66 participants at risk
Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.5%
1/66
|
0.00%
0/65
|
0.00%
0/66
|
Other adverse events
| Measure |
Indacaterol 300 μg
n=66 participants at risk
Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
Salmeterol 50 μg
n=65 participants at risk
Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. 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=66 participants at risk
Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. 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.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/66
|
0.00%
0/65
|
6.1%
4/66
|
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