Trial Outcomes & Findings for Investigation of the 24 Hour Forced Expiratory Flow in 1 Second (FEV1) Profile of a Single Dose of Indacaterol/Mometasone Delivered Via the TWISTHALER® Device in Adult Patients With Persistent Asthma (NCT NCT00557440)
NCT ID: NCT00557440
Last Updated: 2013-03-21
Results Overview
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from the period baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).
Results posted on
2013-03-21
Participant Flow
Participant milestones
| Measure |
Ind/M - FP/Salm - Pbo
In Treatment Period 1 (Days 1 \& 2) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
In Treatment Period 2 (Days 8 \& 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone /salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 3 (Days 15 \& 16) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
Each treatment period was separated by a 6-day washout period.
|
FP/Salm - Pbo - Ind/M
In Treatment Period 1 (Days 1 \& 2) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 2 (Days 8 \& 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 3 (Days 15 \& 16) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
Each treatment period was separated by a 6-day washout period.
|
Pbo - Ind/M - FP/Salm
In Treatment Period 1 (Days 1 \& 2) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 2 (Days 8 \& 9) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 3 (Days 15 \& 16) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.
Each treatment period was separated by a 6-day washout period.
|
|---|---|---|---|
|
Treatment Period 1
STARTED
|
12
|
12
|
13
|
|
Treatment Period 1
COMPLETED
|
12
|
12
|
12
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
1
|
|
Treatment Period 2
STARTED
|
12
|
12
|
12
|
|
Treatment Period 2
COMPLETED
|
12
|
12
|
12
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
|
Treatment Period 3
STARTED
|
12
|
12
|
12
|
|
Treatment Period 3
COMPLETED
|
12
|
12
|
12
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Ind/M - FP/Salm - Pbo
In Treatment Period 1 (Days 1 \& 2) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
In Treatment Period 2 (Days 8 \& 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone /salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 3 (Days 15 \& 16) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
Each treatment period was separated by a 6-day washout period.
|
FP/Salm - Pbo - Ind/M
In Treatment Period 1 (Days 1 \& 2) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 2 (Days 8 \& 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 3 (Days 15 \& 16) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
Each treatment period was separated by a 6-day washout period.
|
Pbo - Ind/M - FP/Salm
In Treatment Period 1 (Days 1 \& 2) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 2 (Days 8 \& 9) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 3 (Days 15 \& 16) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.
Each treatment period was separated by a 6-day washout period.
|
|---|---|---|---|
|
Treatment Period 1
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
Investigation of the 24 Hour Forced Expiratory Flow in 1 Second (FEV1) Profile of a Single Dose of Indacaterol/Mometasone Delivered Via the TWISTHALER® Device in Adult Patients With Persistent Asthma
Baseline characteristics by cohort
| Measure |
Ind/M - FP/Salm - Pbo
n=12 Participants
In Treatment Period 1 (Days 1 \& 2) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
In Treatment Period 2 (Days 8 \& 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone /salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 3 (Days 15 \& 16) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
Each treatment period was separated by a 6-day washout period.
|
FP/Salm - Pbo - Ind/M
n=12 Participants
In Treatment Period 1 (Days 1 \& 2) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 2 (Days 8 \& 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 3 (Days 15 \& 16) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
Each treatment period was separated by a 6-day washout period.
|
Pbo - Ind/M - FP/Salm
n=13 Participants
In Treatment Period 1 (Days 1 \& 2) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 2 (Days 8 \& 9) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 3 (Days 15 \& 16) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.
Each treatment period was separated by a 6-day washout period.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
40.2 years
STANDARD_DEVIATION 15.37 • n=5 Participants
|
50.5 years
STANDARD_DEVIATION 12.00 • n=7 Participants
|
52.5 years
STANDARD_DEVIATION 10.46 • n=5 Participants
|
47.9 years
STANDARD_DEVIATION 13.51 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).Population: The Intent-To-Treat (ITT) population included all randomized patients who had at least one period containing a Baseline FEV1 measurement and at least one post-baseline measurement of FEV1 for the same treatment period. Patients who took rescue medication within 6 hours prior to the trough measurements were excluded from the analysis.
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from the period baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect.
Outcome measures
| Measure |
Indacaterol/Mometasone
n=36 Participants
Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
|
Fluticasone/Salmeterol
n=36 Participants
Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
|
Placebo
n=35 Participants
Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
|
|---|---|---|---|
|
Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)
|
0.081 liters
Standard Error 0.0473
|
0.049 liters
Standard Error 0.0472
|
-0.083 liters
Standard Error 0.0475
|
SECONDARY outcome
Timeframe: 5, 30 minutes, 1, 2, 3, 4 hours, 11 hours 10 minutes, 11 hours 45 minutes, 12 hours 30 minutes, 14, 16, 18, 20, 22 hours, 23 hours 10 minutes, and 23 hours 45 minutes post-dosing.Population: Intent-to-treat population, where data were available. Patients who took rescue medication within 6 hours prior to spirometry measurements were excluded from the analysis. N indicates the number of participants with available data at each time point.
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect.
Outcome measures
| Measure |
Indacaterol/Mometasone
n=36 Participants
Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
|
Fluticasone/Salmeterol
n=36 Participants
Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
|
Placebo
n=37 Participants
Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points
5 minutes [N=36, 36, 37]
|
2.713 liters
Standard Error 0.0302
|
2.632 liters
Standard Error 0.0302
|
2.554 liters
Standard Error 0.0300
|
|
Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points
3 hours [N=36, 36, 36]
|
2.728 liters
Standard Error 0.0411
|
2.724 liters
Standard Error 0.0410
|
2.425 liters
Standard Error 0.0411
|
|
Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points
11 hours 45 minutes [N=36, 35, 32]
|
2.628 liters
Standard Error 0.0492
|
2.518 liters
Standard Error 0.0495
|
2.276 liters
Standard Error 0.0509
|
|
Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points
12 hours 30 minutes [N=36, 35, 32]
|
2.667 liters
Standard Error 0.0437
|
2.659 liters
Standard Error 0.0440
|
2.359 liters
Standard Error 0.0453
|
|
Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points
14 hours [N=36, 35, 32]
|
2.766 liters
Standard Error 0.0433
|
2.779 liters
Standard Error 0.0436
|
2.485 liters
Standard Error 0.0448
|
|
Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points
23 hours 45 minutes [N=36, 36, 34]
|
2.686 liters
Standard Error 0.0459
|
2.640 liters
Standard Error 0.0458
|
2.523 liters
Standard Error 0.0464
|
|
Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points
23 hours 10 minutes [N=35, 36, 35]
|
2.696 liters
Standard Error 0.0517
|
2.676 liters
Standard Error 0.0510
|
2.530 liters
Standard Error 0.0513
|
|
Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points
24 hours post-dose trough [N=36, 36, 35]
|
2.689 liters
Standard Error 0.0473
|
2.656 liters
Standard Error 0.0472
|
2.524 liters
Standard Error 0.0475
|
|
Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points
4 hours [N=36, 36, 35]
|
2.705 liters
Standard Error 0.0434
|
2.669 liters
Standard Error 0.0434
|
2.376 liters
Standard Error 0.0437
|
|
Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points
11 hours 10 minutes [N=36, 35, 34]
|
2.685 liters
Standard Error 0.0496
|
2.570 liters
Standard Error 0.0499
|
2.295 liters
Standard Error 0.0505
|
|
Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points
16 hours [N=36, 35, 31]
|
2.720 liters
Standard Error 0.0493
|
2.681 liters
Standard Error 0.0497
|
2.454 liters
Standard Error 0.0515
|
|
Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points
18 hours [N=35, 36, 33]
|
2.729 liters
Standard Error 0.0395
|
2.717 liters
Standard Error 0.0389
|
2.513 liters
Standard Error 0.0398
|
|
Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points
20 hours [N=35, 36, 34]
|
2.725 liters
Standard Error 0.0475
|
2.707 liters
Standard Error 0.0467
|
2.479 liters
Standard Error 0.0475
|
|
Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points
22 hours [N=35, 36, 34]
|
2.674 liters
Standard Error 0.0493
|
2.695 liters
Standard Error 0.0485
|
2.487 liters
Standard Error 0.0493
|
|
Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points
30 minutes [N=36, 36, 36]
|
2.754 liters
Standard Error 0.0316
|
2.719 liters
Standard Error 0.0316
|
2.527 liters
Standard Error 0.0316
|
|
Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points
1 hour [N=36, 36, 36]
|
2.760 liters
Standard Error 0.0350
|
2.771 liters
Standard Error 0.0350
|
2.525 liters
Standard Error 0.0350
|
|
Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points
2 hours [N=36, 36, 36]
|
2.754 liters
Standard Error 0.0400
|
2.734 liters
Standard Error 0.0399
|
2.483 liters
Standard Error 0.0400
|
SECONDARY outcome
Timeframe: Pre-dose, 5, 30 minutes, 1, 2, 3, 4 hours, 11 hours 10 minutes, 11 hours 45 minutes, 12 hours 30 minutes, 14, 16, 18, 20, 22 hours, 23 hours 10 minutes, and 23 hours 45 minutes post-dosing.Population: Intent-to-treat population, where data were available. Patients who took rescue medication within 6 hours prior to spirometry measurements were excluded from the analysis. N indicates the number of participants with available data at each time point.
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was measured pre-dose and up to 24 hours post-dose. The FEV1 standardized area under the curve (AUC) was analyzed for four time intervals: * Baseline (pre-dose) to 4 hours (hr) post-dosing; * Baseline (pre-dose) to 23 hours, 45 minutes (min) post-dosing; * 11 hours, 10 minutes to 12 hours, 30 minutes post-dosing; * 11 hours, 10 minutes to 23 hours, 45 minutes post-dosing. AUC for FEV1 was analyzed using Analysis of Covariance adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect.
Outcome measures
| Measure |
Indacaterol/Mometasone
n=36 Participants
Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
|
Fluticasone/Salmeterol
n=36 Participants
Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
|
Placebo
n=37 Participants
Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) Standardized Area Under the Curve (AUC) Between Baseline (Pre-dose) and 24 Hours Post-dose
Baseline to 4 hours [N=36, 36, 37]
|
2.730 liters
Standard Error 0.0327
|
2.713 liters
Standard Error 0.0327
|
2.469 liters
Standard Error 0.0326
|
|
Forced Expiratory Volume in 1 Second (FEV1) Standardized Area Under the Curve (AUC) Between Baseline (Pre-dose) and 24 Hours Post-dose
Baseline to 23 hours, 45 minutes [N=36, 36, 37]
|
2.718 liters
Standard Error 0.0376
|
2.679 liters
Standard Error 0.0376
|
2.430 liters
Standard Error 0.0374
|
|
Forced Expiratory Volume in 1 Second (FEV1) Standardized Area Under the Curve (AUC) Between Baseline (Pre-dose) and 24 Hours Post-dose
11 hr, 10 min to 12 hr, 30 min [N=36, 35, 34]
|
2.667 liters
Standard Error 0.0443
|
2.585 liters
Standard Error 0.0445
|
2.314 liters
Standard Error 0.0451
|
|
Forced Expiratory Volume in 1 Second (FEV1) Standardized Area Under the Curve (AUC) Between Baseline (Pre-dose) and 24 Hours Post-dose
11 hr, 10 min to 23 hr, 45min [N=36, 36, 36]
|
2.726 liters
Standard Error 0.0435
|
2.696 liters
Standard Error 0.0435
|
2.470 liters
Standard Error 0.0436
|
SECONDARY outcome
Timeframe: Up to 4 hours post-dosePopulation: Intent-to-treat population, where data were available. Patients who took rescue medication within 6 hours prior to spirometry measurements were excluded from the analysis.
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1 during the first 4 hours post-dose. Time to peak FEV1 is based on log-transformed analysis of variance adjusted for treatment, period, sequence and center, with patient nested within sequence as a random effect. Geometric Mean was obtained by taking anti-logs of the adjusted means from the model and standard error was calculated using the delta method.
Outcome measures
| Measure |
Indacaterol/Mometasone
n=36 Participants
Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
|
Fluticasone/Salmeterol
n=36 Participants
Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
|
Placebo
n=37 Participants
Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
|
|---|---|---|---|
|
Time to Peak Forced Expiratory Volume in 1 Second (FEV1)
|
87.4 minutes
Standard Error 16.98
|
67.7 minutes
Standard Error 13.16
|
22.3 minutes
Standard Error 4.30
|
SECONDARY outcome
Timeframe: 5, 30 minutes, 1, 2, 3, 4 hours, 11 hours 10 minutes, 11 hours 45 minutes, 12 hours 30 minutes, 14, 16, 18, 20, 22 hours, 23 hours 10 minutes, and 23 hours 45 minutes post-dosing.Population: Intent-to-treat population, where data were available. Patients who took rescue medication within 6 hours prior to spirometry measurements were excluded from the analysis. N indicates the number of participants with available data at each time point.
Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was analyzed using ANCOVA adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect.
Outcome measures
| Measure |
Indacaterol/Mometasone
n=36 Participants
Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
|
Fluticasone/Salmeterol
n=36 Participants
Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
|
Placebo
n=37 Participants
Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
|
|---|---|---|---|
|
Forced Vital Capacity (FVC) at Single Time Points
30 minutes [N= 36, 36, 36]
|
3.946 liters
Standard Error 0.0338
|
3.933 liters
Standard Error 0.0338
|
3.839 liters
Standard Error 0.0338
|
|
Forced Vital Capacity (FVC) at Single Time Points
1 hour [N= 36, 36, 36]
|
3.945 liters
Standard Error 0.0337
|
3.955 liters
Standard Error 0.0337
|
3.808 liters
Standard Error 0.0337
|
|
Forced Vital Capacity (FVC) at Single Time Points
2 hours [N= 36, 36, 36]
|
4.080 liters
Standard Error 0.1074
|
3.899 liters
Standard Error 0.1073
|
3.742 liters
Standard Error 0.1073
|
|
Forced Vital Capacity (FVC) at Single Time Points
5 minutes [N= 36, 36, 37]
|
3.917 liters
Standard Error 0.0333
|
3.880 liters
Standard Error 0.0333
|
3.830 liters
Standard Error 0.0331
|
|
Forced Vital Capacity (FVC) at Single Time Points
3 hours [N= 36, 36, 36]
|
3.925 liters
Standard Error 0.0390
|
3.923 liters
Standard Error 0.0390
|
3.708 liters
Standard Error 0.0391
|
|
Forced Vital Capacity (FVC) at Single Time Points
4 hours [N= 36, 36, 35]
|
3.857 liters
Standard Error 0.0438
|
3.861 liters
Standard Error 0.0438
|
3.665 liters
Standard Error 0.0442
|
|
Forced Vital Capacity (FVC) at Single Time Points
11 hours 10 minutes [N= 36, 35, 34]
|
3.896 liters
Standard Error 0.0569
|
3.828 liters
Standard Error 0.0573
|
3.632 liters
Standard Error 0.0581
|
|
Forced Vital Capacity (FVC) at Single Time Points
11 hours 45 minutes [N= 36, 35, 32]
|
3.837 liters
Standard Error 0.0549
|
3.736 liters
Standard Error 0.0553
|
3.607 liters
Standard Error 0.0570
|
|
Forced Vital Capacity (FVC) at Single Time Points
12 hours 30 minutes [N= 36, 35, 32]
|
3.833 liters
Standard Error 0.0496
|
3.841 liters
Standard Error 0.0500
|
3.680 liters
Standard Error 0.0518
|
|
Forced Vital Capacity (FVC) at Single Time Points
14 hours [N= 36, 35, 32]
|
3.918 liters
Standard Error 0.0506
|
3.894 liters
Standard Error 0.0510
|
3.759 liters
Standard Error 0.0528
|
|
Forced Vital Capacity (FVC) at Single Time Points
16 hours [N= 36, 35, 31]
|
3.896 liters
Standard Error 0.0524
|
3.787 liters
Standard Error 0.0528
|
3.737 liters
Standard Error 0.0551
|
|
Forced Vital Capacity (FVC) at Single Time Points
18 hours [N= 35, 36, 33]
|
3.893 liters
Standard Error 0.0462
|
3.866 liters
Standard Error 0.0455
|
3.784 liters
Standard Error 0.0466
|
|
Forced Vital Capacity (FVC) at Single Time Points
20 hours [N= 35, 36, 34]
|
3.903 liters
Standard Error 0.0499
|
3.848 liters
Standard Error 0.0492
|
3.764 liters
Standard Error 0.0499
|
|
Forced Vital Capacity (FVC) at Single Time Points
22 hours [N= 35, 36, 34]
|
3.865 liters
Standard Error 0.0453
|
3.906 liters
Standard Error 0.0446
|
3.764 liters
Standard Error 0.0453
|
|
Forced Vital Capacity (FVC) at Single Time Points
23 hours 10 minutes [N= 35, 36, 35]
|
3.870 liters
Standard Error 0.0519
|
3.866 liters
Standard Error 0.0512
|
3.808 liters
Standard Error 0.0516
|
|
Forced Vital Capacity (FVC) at Single Time Points
23 hours 45 minutes [N=36, 36, 34]
|
3.866 liters
Standard Error 0.0509
|
3.825 liters
Standard Error 0.0509
|
3.817 liters
Standard Error 0.0516
|
Adverse Events
Indacaterol/Mometasone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Fluticasone/Salmeterol
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Indacaterol/Mometasone
n=36 participants at risk
Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
|
Fluticasone/Salmeterol
n=36 participants at risk
Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
|
Placebo
n=37 participants at risk
Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
5.6%
2/36
|
2.8%
1/36
|
5.4%
2/37
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER