Trial Outcomes & Findings for A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via the TWISTHALER® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00557466)
NCT ID: NCT00557466
Last Updated: 2013-01-18
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 baseline to 24 hour post dose trough FEV1 after 14 days of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
568 participants
Primary outcome timeframe
Baseline (prior to first dose) and Day 15 (24 hours after last dose)
Results posted on
2013-01-18
Participant Flow
Participant milestones
| Measure |
Indacaterol 62.5 μg
Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 125 μg
Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 250 μg
Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 500 μg
Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Formoterol
Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
|
Placebo
Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
98
|
92
|
101
|
96
|
90
|
91
|
|
Overall Study
Safety Population
|
98
|
92
|
101
|
96
|
90
|
91
|
|
Overall Study
Intent to Treat Population
|
98
|
91
|
98
|
93
|
87
|
89
|
|
Overall Study
COMPLETED
|
94
|
87
|
95
|
92
|
87
|
85
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
6
|
4
|
3
|
6
|
Reasons for withdrawal
| Measure |
Indacaterol 62.5 μg
Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 125 μg
Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 250 μg
Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 500 μg
Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Formoterol
Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
|
Placebo
Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
4
|
1
|
2
|
4
|
|
Overall Study
Abnormal laboratory value(s)
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol deviation
|
0
|
1
|
0
|
2
|
0
|
0
|
|
Overall Study
Subject withdrew consent
|
0
|
0
|
0
|
0
|
1
|
2
|
|
Overall Study
Administrative problems
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Abnormal test procedure results
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via the TWISTHALER® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Indacaterol 62.5 μg
n=98 Participants
Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 125 μg
n=91 Participants
Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 250 μg
n=98 Participants
Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 500 μg
n=93 Participants
Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Formoterol
n=87 Participants
Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
|
Placebo
n=89 Participants
Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Total
n=556 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age Continuous
|
62.1 years
STANDARD_DEVIATION 7.69 • n=5 Participants
|
61.6 years
STANDARD_DEVIATION 9.51 • n=7 Participants
|
61.6 years
STANDARD_DEVIATION 8.68 • n=5 Participants
|
61.9 years
STANDARD_DEVIATION 8.48 • n=4 Participants
|
63.3 years
STANDARD_DEVIATION 8.36 • n=21 Participants
|
62.2 years
STANDARD_DEVIATION 8.84 • n=10 Participants
|
62.1 years
STANDARD_DEVIATION 8.58 • n=115 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
157 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
64 Participants
n=10 Participants
|
399 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose) and Day 15 (24 hours after last dose)Population: The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data.
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 14 days of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.
Outcome measures
| Measure |
Indacaterol 62.5 μg
n=92 Participants
Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 125 μg
n=85 Participants
Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 250 μg
n=90 Participants
Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 500 μg
n=89 Participants
Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Formoterol
n=83 Participants
Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
|
Placebo
n=80 Participants
Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
|---|---|---|---|---|---|---|
|
The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)
|
0.051 liters
Standard Error 0.0207
|
0.073 liters
Standard Error 0.0217
|
0.076 liters
Standard Error 0.0210
|
0.121 liters
Standard Error 0.0211
|
0.098 liters
Standard Error 0.0219
|
0.005 liters
Standard Error 0.0223
|
SECONDARY outcome
Timeframe: Day 14, pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.Population: The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only.
FEV1 was measured on Day 14 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.
Outcome measures
| Measure |
Indacaterol 62.5 μg
n=93 Participants
Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 125 μg
n=86 Participants
Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 250 μg
n=90 Participants
Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 500 μg
n=89 Participants
Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Formoterol
n=83 Participants
Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
|
Placebo
n=81 Participants
Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
|---|---|---|---|---|---|---|
|
Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose
|
1.407 liters
Standard Error 0.0193
|
1.461 liters
Standard Error 0.0202
|
1.441 liters
Standard Error 0.0196
|
1.500 liters
Standard Error 0.0198
|
1.541 liters
Standard Error 0.0206
|
1.315 liters
Standard Error 0.0208
|
SECONDARY outcome
Timeframe: Day 1 Baseline (prior to first dose) and 24 hours post-dose.Population: The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data.
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.
Outcome measures
| Measure |
Indacaterol 62.5 μg
n=95 Participants
Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 125 μg
n=88 Participants
Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 250 μg
n=96 Participants
Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 500 μg
n=90 Participants
Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Formoterol
n=86 Participants
Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
|
Placebo
n=87 Participants
Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
|---|---|---|---|---|---|---|
|
The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1
|
0.028 liters
Standard Error 0.0152
|
0.054 liters
Standard Error 0.0158
|
0.060 liters
Standard Error 0.0151
|
0.073 liters
Standard Error 0.0156
|
0.140 liters
Standard Error 0.0160
|
-0.009 liters
Standard Error 0.0160
|
SECONDARY outcome
Timeframe: Day 1; pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.Population: The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only.
FEV1 was measured on Day 1 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.
Outcome measures
| Measure |
Indacaterol 62.5 μg
n=98 Participants
Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 125 μg
n=91 Participants
Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 250 μg
n=97 Participants
Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 500 μg
n=91 Participants
Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Formoterol
n=87 Participants
Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
|
Placebo
n=87 Participants
Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
|---|---|---|---|---|---|---|
|
Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1
|
1.371 liters
Standard Error 0.0111
|
1.422 liters
Standard Error 0.0116
|
1.427 liters
Standard Error 0.0112
|
1.438 liters
Standard Error 0.0116
|
1.535 liters
Standard Error 0.0118
|
1.321 liters
Standard Error 0.0118
|
SECONDARY outcome
Timeframe: Day 1 and Day 14 measured pre-dose and up to 4 hours post-dosePopulation: The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data, indicated by "N".
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, which is taken as the maximum FEV1 recorded post-dose.
Outcome measures
| Measure |
Indacaterol 62.5 μg
n=98 Participants
Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 125 μg
n=91 Participants
Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 250 μg
n=98 Participants
Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 500 μg
n=93 Participants
Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Formoterol
n=87 Participants
Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
|
Placebo
n=89 Participants
Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
|---|---|---|---|---|---|---|
|
Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14
Day 14 [N=93, 86, 90, 89, 83, 82]
|
91.3 minutes
Standard Deviation 81.20
|
105.6 minutes
Standard Deviation 82.53
|
104.7 minutes
Standard Deviation 75.96
|
116.4 minutes
Standard Deviation 85.03
|
89.1 minutes
Standard Deviation 72.91
|
68.0 minutes
Standard Deviation 70.38
|
|
Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14
Day 1 [N=98, 91, 97, 91, 87, 87]
|
80.9 minutes
Standard Deviation 76.01
|
84.4 minutes
Standard Deviation 77.74
|
101.4 minutes
Standard Deviation 83.44
|
105.3 minutes
Standard Deviation 81.85
|
115.0 minutes
Standard Deviation 81.59
|
85.7 minutes
Standard Deviation 81.44
|
SECONDARY outcome
Timeframe: Baseline (recorded during the screening period) and Days 1-14 (treatment period).Population: Intent to treat population. The analysis only includes patients with non-missing data.
The Peak Expiratory Flow (PEF) rate is the maximal rate that a person can exhale during a short maximal expiratory effort after fully inhaling. Participants measured their PEF using a peak flow meter prior to taking study medication and recorded measurements in a diary every morning and evening during the study. Change from baseline is the difference between the mean baseline PEF recorded during the screening period until the first day of treatment, and the overall mean PEF from Days 1 to 14.
Outcome measures
| Measure |
Indacaterol 62.5 μg
n=98 Participants
Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 125 μg
n=91 Participants
Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 250 μg
n=98 Participants
Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 500 μg
n=93 Participants
Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Formoterol
n=87 Participants
Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
|
Placebo
n=89 Participants
Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Morning and Evening Peak Expiratory Flow
Morning [N=56, 63, 59, 54, 54, 55]
|
3.10 liters/minute
Standard Deviation 29.709
|
19.91 liters/minute
Standard Deviation 34.060
|
23.63 liters/minute
Standard Deviation 30.707
|
11.11 liters/minute
Standard Deviation 36.787
|
16.06 liters/minute
Standard Deviation 31.544
|
-4.24 liters/minute
Standard Deviation 31.357
|
|
Change From Baseline in Morning and Evening Peak Expiratory Flow
Evening [N=56, 58, 56, 49, 48, 52]
|
-2.72 liters/minute
Standard Deviation 28.816
|
13.42 liters/minute
Standard Deviation 30.500
|
19.00 liters/minute
Standard Deviation 24.004
|
5.92 liters/minute
Standard Deviation 43.490
|
14.97 liters/minute
Standard Deviation 40.355
|
-2.75 liters/minute
Standard Deviation 35.034
|
SECONDARY outcome
Timeframe: Over 14 daysPopulation: Intent to treat
Participants recorded the use of rescue medications (salbutamol/albuterol) for treatment of asthma symptoms twice a day in a diary during the 14 days of the treatment period.
Outcome measures
| Measure |
Indacaterol 62.5 μg
n=98 Participants
Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 125 μg
n=91 Participants
Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 250 μg
n=98 Participants
Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 500 μg
n=93 Participants
Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Formoterol
n=87 Participants
Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
|
Placebo
n=89 Participants
Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
|---|---|---|---|---|---|---|
|
Number of Participants Using Rescue Medication
Night
|
72 participants
|
60 participants
|
67 participants
|
59 participants
|
67 participants
|
72 participants
|
|
Number of Participants Using Rescue Medication
Day
|
74 participants
|
61 participants
|
73 participants
|
65 participants
|
65 participants
|
70 participants
|
Adverse Events
Indacaterol 62.5 μg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Indacaterol 125 μg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Indacaterol 250 μg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Indacaterol 500 μg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Formoterol
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Indacaterol 62.5 μg
n=98 participants at risk
Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 125 μg
n=92 participants at risk
Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 250 μg
n=101 participants at risk
Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 500 μg
n=96 participants at risk
Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Formoterol
n=90 participants at risk
Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
|
Placebo
n=91 participants at risk
Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/98
|
0.00%
0/92
|
0.00%
0/101
|
1.0%
1/96
|
0.00%
0/90
|
0.00%
0/91
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/98
|
0.00%
0/92
|
0.00%
0/101
|
1.0%
1/96
|
0.00%
0/90
|
0.00%
0/91
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
1.0%
1/98
|
0.00%
0/92
|
0.99%
1/101
|
1.0%
1/96
|
1.1%
1/90
|
1.1%
1/91
|
Other adverse events
| Measure |
Indacaterol 62.5 μg
n=98 participants at risk
Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 125 μg
n=92 participants at risk
Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 250 μg
n=101 participants at risk
Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Indacaterol 500 μg
n=96 participants at risk
Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
Formoterol
n=90 participants at risk
Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
|
Placebo
n=91 participants at risk
Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
NASOPHARYNGITIS
|
2.0%
2/98
|
0.00%
0/92
|
0.99%
1/101
|
1.0%
1/96
|
5.6%
5/90
|
2.2%
2/91
|
|
Nervous system disorders
HEADACHE
|
2.0%
2/98
|
5.4%
5/92
|
2.0%
2/101
|
3.1%
3/96
|
1.1%
1/90
|
6.6%
6/91
|
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