Asthma
Conditions
Keywords
QMF, indacaterol, Twisthaler®
Brief summary
This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.
Interventions
DRUGindacaterol
Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).
DRUGformoterol
Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.
DRUGplacebo to indacaterol
Placebo TWISTHALER® device
Placebo AEROLIZER® device
DRUGshort acting β2-agonist
100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
Sponsors
Schering-Plough
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female adult and adolescent patients aged 12-75 years inclusive (or ≥18-75 years depending upon regulatory and/or Institutional Review Board (IRB)/Independent Ethics Committee (IEC)/Research Ethics Board (REB) approval), who have signed an Informed Consent Form prior to initiation of any study-related procedure, including any adjustments to asthma medication prior to Visit 1. Patients below the legal age of consent are required to have the Informed Consent Form signed by the patient's parent / guardian. 2. Patients with asthma, diagnosed according to Global Initiative for Asthma (GINA) guidelines (National Institute of Health, National Heart, Lung and Blood Institute, 2006) and who additionally meet the following criteria: 1. Patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the package leaflet, in a stable regimen for the month prior to Visit 1. 2. Patients with a Forced Expiratory Volume in one second (FEV1) at Visit 1 of ≥50% of the predicted normal value for the patient. This criterion for FEV1 will have to be demonstrated after a washout period of at least 6 hours during which no short acting β2-agonist has been inhaled, and a minimum of 48 hours for a long acting β2-agonist. 3. Patients who demonstrate an increase of ≥12% and ≥200 mL in FEV1 over their pre-bronchodilator value within 30 minutes after inhaling a total of 200 µg/180 µg of salbutamol/albuterol Metered Dose Inhaler (MDI) (or equivalent dose of Dry Powder Inhaler \[DPI\]) (the reversibility test). Reversibility will have to be demonstrated after an appropriate washout period of at least 6 hrs prior to the evaluation for a short-acting β2-agonist. The administration of salbutamol/albuterol for the reversibility test is to be within 30 minutes after pre bronchodilator spirometry. Reversibility has to be demonstrated at Visit 1 or between Visits 1 and 2, in order for patients to be included in the trial.
Exclusion criteria
* Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception. * Patients with Chronic Obstructive Pulmonary Disease (COPD), or current smokers, or patients who have used tobacco products within the 6 month period prior to Visit 1, or who have a smoking history of greater than 10 pack years. * Patients: 1. who's asthma is likely to deteriorate during the study (including seasonal allergy), 2. hospitalized for an acute asthma attack/asthma exacerbation within 6 months prior to Visit 1, 3. who have had an emergency room visit for an asthma attack/asthma exacerbation within 6 weeks prior to Visit 1 4. who have had a respiratory tract infection or emergency room treatment for an asthma attack/asthma exacerbation within 4 weeks prior to Visit 1 5. Patients who require the use of ≥8 inhalations per day of short acting B2-agonist (100 µg/ 90 µg salbutamol/albuterol MDI or equivalent dose of DPI) on any 2 consecutive days from Screening to Randomization. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) | Baseline (prior to first dose) and Day 15 (24 hours after last dose) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1 | Day 1 Baseline (prior to first dose) and 24 hours post-dose. | 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. |
| Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1 | Day 1, pre-dose, 5, 20 and 30 minutes, 1, 2, 3, and 4 hours post-dose. | 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. |
| Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose | Day 14, pre-dose, 5, 20 and 30 minutes, 1, 2, 3, and 4 hours post-dose. | 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. |
| Change From Baseline in Morning and Evening Peak Expiratory Flow | Baseline (recorded during the screening period) and Days 1-14 (treatment period) | 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 and recorded measurements in a diary every morning and evening during the study, prior to taking study medication. 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. |
| Number of Participants Using Rescue Medication | Over 14 days | 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. |
| Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14 | Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose | 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. |
Countries
Belgium, Czechia, Germany, Hungary, Israel, Poland, Russia, South Africa, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 61 |
| 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. | 68 |
| 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. | 65 |
| 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. | 72 |
| 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. | 64 |
| Placebo Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. | 62 |
| Total | 392 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Abnormal laboratory value(s) | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Abnormal test procedure result(s) | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Protocol deviation | 0 | 1 | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Indacaterol 62.5 μg | Indacaterol 125 μg | Indacaterol 250 μg | Indacaterol 500 μg | Formoterol | Placebo | Total |
|---|---|---|---|---|---|---|---|
| Age Continuous | 41.3 years STANDARD_DEVIATION 16.27 | 38.4 years STANDARD_DEVIATION 17.25 | 36.6 years STANDARD_DEVIATION 15.76 | 40.1 years STANDARD_DEVIATION 15.47 | 44.0 years STANDARD_DEVIATION 17.98 | 39.8 years STANDARD_DEVIATION 15.82 | 40.0 years STANDARD_DEVIATION 16.5 |
| Sex: Female, Male Female | 28 Participants | 37 Participants | 36 Participants | 39 Participants | 27 Participants | 37 Participants | 204 Participants |
| Sex: Female, Male Male | 33 Participants | 31 Participants | 29 Participants | 33 Participants | 37 Participants | 25 Participants | 188 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 61 | 2 / 68 | 4 / 65 | 8 / 72 | 0 / 64 | 1 / 62 |
| serious Total, serious adverse events | 0 / 61 | 0 / 68 | 0 / 65 | 0 / 72 | 0 / 64 | 1 / 62 |
Outcome results
Primary
The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Indacaterol 62.5 μg | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) | 0.039 liters | Standard Error 0.0408 |
| Indacaterol 125 μg | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) | 0.054 liters | Standard Error 0.0383 |
| Indacaterol 250 μg | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) | 0.124 liters | Standard Error 0.0401 |
| Indacaterol 500 μg | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) | 0.166 liters | Standard Error 0.0381 |
| Formoterol | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) | 0.075 liters | Standard Error 0.0405 |
| Placebo | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) | -0.018 liters | Standard Error 0.0415 |
Secondary
Change From Baseline in Morning and Evening Peak Expiratory Flow
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 and recorded measurements in a diary every morning and evening during the study, prior to taking study medication. 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.
Time frame: 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, indicated by N.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Indacaterol 62.5 μg | Change From Baseline in Morning and Evening Peak Expiratory Flow | Morning [N=56, 61, 53, 63, 57, 48] | 18.7 liters/minute | Standard Deviation 29.28 |
| Indacaterol 62.5 μg | Change From Baseline in Morning and Evening Peak Expiratory Flow | Evening [N=56, 58, 54, 59, 55, 47] | 5.9 liters/minute | Standard Deviation 36.92 |
| Indacaterol 125 μg | Change From Baseline in Morning and Evening Peak Expiratory Flow | Morning [N=56, 61, 53, 63, 57, 48] | 17.2 liters/minute | Standard Deviation 34.07 |
| Indacaterol 125 μg | Change From Baseline in Morning and Evening Peak Expiratory Flow | Evening [N=56, 58, 54, 59, 55, 47] | 4.2 liters/minute | Standard Deviation 37.82 |
| Indacaterol 250 μg | Change From Baseline in Morning and Evening Peak Expiratory Flow | Morning [N=56, 61, 53, 63, 57, 48] | 25.7 liters/minute | Standard Deviation 38.37 |
| Indacaterol 250 μg | Change From Baseline in Morning and Evening Peak Expiratory Flow | Evening [N=56, 58, 54, 59, 55, 47] | 18.4 liters/minute | Standard Deviation 36.7 |
| Indacaterol 500 μg | Change From Baseline in Morning and Evening Peak Expiratory Flow | Morning [N=56, 61, 53, 63, 57, 48] | 25.8 liters/minute | Standard Deviation 47.36 |
| Indacaterol 500 μg | Change From Baseline in Morning and Evening Peak Expiratory Flow | Evening [N=56, 58, 54, 59, 55, 47] | 25.8 liters/minute | Standard Deviation 38.07 |
| Formoterol | Change From Baseline in Morning and Evening Peak Expiratory Flow | Morning [N=56, 61, 53, 63, 57, 48] | 25.2 liters/minute | Standard Deviation 38.28 |
| Formoterol | Change From Baseline in Morning and Evening Peak Expiratory Flow | Evening [N=56, 58, 54, 59, 55, 47] | 26.2 liters/minute | Standard Deviation 35.01 |
| Placebo | Change From Baseline in Morning and Evening Peak Expiratory Flow | Morning [N=56, 61, 53, 63, 57, 48] | -4.3 liters/minute | Standard Deviation 43 |
| Placebo | Change From Baseline in Morning and Evening Peak Expiratory Flow | Evening [N=56, 58, 54, 59, 55, 47] | -11.4 liters/minute | Standard Deviation 50.73 |
Secondary
Number of Participants Using Rescue Medication
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.
Time frame: Over 14 days
Population: Intent to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Indacaterol 62.5 μg | Number of Participants Using Rescue Medication | Day | 33 participants |
| Indacaterol 62.5 μg | Number of Participants Using Rescue Medication | Night | 36 participants |
| Indacaterol 125 μg | Number of Participants Using Rescue Medication | Night | 40 participants |
| Indacaterol 125 μg | Number of Participants Using Rescue Medication | Day | 43 participants |
| Indacaterol 250 μg | Number of Participants Using Rescue Medication | Day | 28 participants |
| Indacaterol 250 μg | Number of Participants Using Rescue Medication | Night | 36 participants |
| Indacaterol 500 μg | Number of Participants Using Rescue Medication | Night | 34 participants |
| Indacaterol 500 μg | Number of Participants Using Rescue Medication | Day | 35 participants |
| Formoterol | Number of Participants Using Rescue Medication | Night | 31 participants |
| Formoterol | Number of Participants Using Rescue Medication | Day | 30 participants |
| Placebo | Number of Participants Using Rescue Medication | Day | 39 participants |
| Placebo | Number of Participants Using Rescue Medication | Night | 40 participants |
Secondary
Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose
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.
Time frame: Day 14, pre-dose, 5, 20 and 30 minutes, 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Indacaterol 62.5 μg | Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose | 2.670 liters | Standard Error 0.0419 |
| Indacaterol 125 μg | Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose | 2.698 liters | Standard Error 0.04 |
| Indacaterol 250 μg | Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose | 2.772 liters | Standard Error 0.0411 |
| Indacaterol 500 μg | Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose | 2.786 liters | Standard Error 0.0393 |
| Formoterol | Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose | 2.821 liters | Standard Error 0.0418 |
| Placebo | Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose | 2.565 liters | Standard Error 0.0426 |
Secondary
Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1
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.
Time frame: Day 1, pre-dose, 5, 20 and 30 minutes, 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Indacaterol 62.5 μg | Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1 | 2.668 liters | Standard Error 0.0281 |
| Indacaterol 125 μg | Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1 | 2.687 liters | Standard Error 0.0264 |
| Indacaterol 250 μg | Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1 | 2.726 liters | Standard Error 0.0272 |
| Indacaterol 500 μg | Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1 | 2.753 liters | Standard Error 0.0259 |
| Formoterol | Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1 | 2.832 liters | Standard Error 0.0274 |
| Placebo | Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1 | 2.547 liters | Standard Error 0.0279 |
Secondary
The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Indacaterol 62.5 μg | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1 | 0.054 liters | Standard Error 0.0347 |
| Indacaterol 125 μg | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1 | 0.081 liters | Standard Error 0.0326 |
| Indacaterol 250 μg | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1 | 0.143 liters | Standard Error 0.0339 |
| Indacaterol 500 μg | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1 | 0.141 liters | Standard Error 0.0326 |
| Formoterol | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1 | 0.155 liters | Standard Error 0.0341 |
| Placebo | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1 | 0.010 liters | Standard Error 0.0344 |
Secondary
Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14
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.
Time frame: Day 1 and Day 14 measured pre-dose and up to 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. The analysis only includes patients with non-missing data, indicated by N.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Indacaterol 62.5 μg | Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14 | Day 1 [N=61, 68, 65, 71, 64, 62] | 91.0 minutes | Standard Deviation 83.02 |
| Indacaterol 62.5 μg | Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14 | Day 14 [N=61, 66, 64, 70, 62, 59] | 103.8 minutes | Standard Deviation 86.67 |
| Indacaterol 125 μg | Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14 | Day 1 [N=61, 68, 65, 71, 64, 62] | 109.6 minutes | Standard Deviation 81.09 |
| Indacaterol 125 μg | Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14 | Day 14 [N=61, 66, 64, 70, 62, 59] | 118.7 minutes | Standard Deviation 88.42 |
| Indacaterol 250 μg | Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14 | Day 1 [N=61, 68, 65, 71, 64, 62] | 119.0 minutes | Standard Deviation 81.64 |
| Indacaterol 250 μg | Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14 | Day 14 [N=61, 66, 64, 70, 62, 59] | 96.7 minutes | Standard Deviation 70.65 |
| Indacaterol 500 μg | Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14 | Day 1 [N=61, 68, 65, 71, 64, 62] | 116.2 minutes | Standard Deviation 75.5 |
| Indacaterol 500 μg | Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14 | Day 14 [N=61, 66, 64, 70, 62, 59] | 114.0 minutes | Standard Deviation 76.41 |
| Formoterol | Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14 | Day 1 [N=61, 68, 65, 71, 64, 62] | 105.6 minutes | Standard Deviation 70.64 |
| Formoterol | Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14 | Day 14 [N=61, 66, 64, 70, 62, 59] | 114.6 minutes | Standard Deviation 71.64 |
| Placebo | Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14 | Day 1 [N=61, 68, 65, 71, 64, 62] | 90.5 minutes | Standard Deviation 82.46 |
| Placebo | Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14 | Day 14 [N=61, 66, 64, 70, 62, 59] | 80.4 minutes | Standard Deviation 76.92 |