COPD
Conditions
Keywords
QMF, indacaterol, TWISTHALER® device
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
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure (which include any adjustment to their current COPD treatment) * Cooperative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines, 2006) and: * Smoking history of at least 10 pack years * Post-bronchodilator Forced Expiratory Volume in one second (FEV1) \< 80% and ≥30% of the predicted normal value. * Post-bronchodilator FEV1/Forced vital capacity (FVC) \< 70%
Exclusion criteria
* Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using acceptable methods of contraception. * Patients who have been hospitalized for an exacerbation of their airways disease within 6 weeks prior to Visit 1 or between Visit 1 and Visit 2. * Patients with a history of asthma. * Patients with an acute respiratory tract infection within 4 weeks prior to Visit 1, will be not allowed to enter the study. * Other clinically significant conditions which may interfere with the study conduct or patient safety as specified in the protocol. 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 |
|---|---|---|
| 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 and at 5, 20, 30 minutes and 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. |
| 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 and at 5, 20, 30 minutes and 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. |
| 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. |
| 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 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. |
| 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. |
Countries
Argentina, Belgium, Chile, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Norway, Peru, Poland, Romania, South Africa, Turkey (Türkiye), 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. | 98 |
| 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. | 91 |
| 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. | 98 |
| 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. | 93 |
| 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. | 87 |
| Placebo Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. | 89 |
| Total | 556 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Abnormal laboratory value(s) | 1 | 2 | 0 | 0 | 0 | 0 |
| Overall Study | Abnormal test procedure results | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Administrative problems | 0 | 1 | 1 | 0 | 0 | 0 |
| Overall Study | Adverse Event | 3 | 1 | 4 | 1 | 2 | 4 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Protocol deviation | 0 | 1 | 0 | 2 | 0 | 0 |
| Overall Study | Subject withdrew consent | 0 | 0 | 0 | 0 | 1 | 2 |
Baseline characteristics
| Characteristic | Indacaterol 62.5 μg | Indacaterol 125 μg | Indacaterol 250 μg | Indacaterol 500 μg | Formoterol | Placebo | Total |
|---|---|---|---|---|---|---|---|
| Age Continuous | 62.1 years STANDARD_DEVIATION 7.69 | 61.6 years STANDARD_DEVIATION 9.51 | 61.6 years STANDARD_DEVIATION 8.68 | 61.9 years STANDARD_DEVIATION 8.48 | 63.3 years STANDARD_DEVIATION 8.36 | 62.2 years STANDARD_DEVIATION 8.84 | 62.1 years STANDARD_DEVIATION 8.58 |
| Sex: Female, Male Female | 33 Participants | 23 Participants | 27 Participants | 20 Participants | 29 Participants | 25 Participants | 157 Participants |
| Sex: Female, Male Male | 65 Participants | 68 Participants | 71 Participants | 73 Participants | 58 Participants | 64 Participants | 399 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 | 4 / 98 | 5 / 92 | 3 / 101 | 4 / 96 | 6 / 90 | 8 / 91 |
| serious Total, serious adverse events | 1 / 98 | 0 / 92 | 1 / 101 | 2 / 96 | 1 / 90 | 1 / 91 |
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) | 0.051 liters | Standard Error 0.0207 |
| Indacaterol 125 μg | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) | 0.073 liters | Standard Error 0.0217 |
| Indacaterol 250 μg | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) | 0.076 liters | Standard Error 0.021 |
| Indacaterol 500 μg | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) | 0.121 liters | Standard Error 0.0211 |
| Formoterol | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) | 0.098 liters | Standard Error 0.0219 |
| Placebo | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) | 0.005 liters | Standard Error 0.0223 |
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 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.
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Indacaterol 62.5 μg | 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 |
| Indacaterol 62.5 μg | 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 |
| Indacaterol 125 μg | Change From Baseline in Morning and Evening Peak Expiratory Flow | Morning [N=56, 63, 59, 54, 54, 55] | 19.91 liters/minute | Standard Deviation 34.06 |
| Indacaterol 125 μg | Change From Baseline in Morning and Evening Peak Expiratory Flow | Evening [N=56, 58, 56, 49, 48, 52] | 13.42 liters/minute | Standard Deviation 30.5 |
| Indacaterol 250 μg | Change From Baseline in Morning and Evening Peak Expiratory Flow | Morning [N=56, 63, 59, 54, 54, 55] | 23.63 liters/minute | Standard Deviation 30.707 |
| Indacaterol 250 μg | Change From Baseline in Morning and Evening Peak Expiratory Flow | Evening [N=56, 58, 56, 49, 48, 52] | 19.00 liters/minute | Standard Deviation 24.004 |
| Indacaterol 500 μg | Change From Baseline in Morning and Evening Peak Expiratory Flow | Morning [N=56, 63, 59, 54, 54, 55] | 11.11 liters/minute | Standard Deviation 36.787 |
| Indacaterol 500 μg | Change From Baseline in Morning and Evening Peak Expiratory Flow | Evening [N=56, 58, 56, 49, 48, 52] | 5.92 liters/minute | Standard Deviation 43.49 |
| Formoterol | Change From Baseline in Morning and Evening Peak Expiratory Flow | Morning [N=56, 63, 59, 54, 54, 55] | 16.06 liters/minute | Standard Deviation 31.544 |
| Formoterol | Change From Baseline in Morning and Evening Peak Expiratory Flow | Evening [N=56, 58, 56, 49, 48, 52] | 14.97 liters/minute | Standard Deviation 40.355 |
| Placebo | Change From Baseline in Morning and Evening Peak Expiratory Flow | Morning [N=56, 63, 59, 54, 54, 55] | -4.24 liters/minute | Standard Deviation 31.357 |
| Placebo | Change From Baseline in Morning and Evening Peak Expiratory Flow | Evening [N=56, 58, 56, 49, 48, 52] | -2.75 liters/minute | Standard Deviation 35.034 |
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 | Night | 72 participants |
| Indacaterol 62.5 μg | Number of Participants Using Rescue Medication | Day | 74 participants |
| Indacaterol 125 μg | Number of Participants Using Rescue Medication | Day | 61 participants |
| Indacaterol 125 μg | Number of Participants Using Rescue Medication | Night | 60 participants |
| Indacaterol 250 μg | Number of Participants Using Rescue Medication | Night | 67 participants |
| Indacaterol 250 μg | Number of Participants Using Rescue Medication | Day | 73 participants |
| Indacaterol 500 μg | Number of Participants Using Rescue Medication | Night | 59 participants |
| Indacaterol 500 μg | Number of Participants Using Rescue Medication | Day | 65 participants |
| Formoterol | Number of Participants Using Rescue Medication | Day | 65 participants |
| Formoterol | Number of Participants Using Rescue Medication | Night | 67 participants |
| Placebo | Number of Participants Using Rescue Medication | Day | 70 participants |
| Placebo | Number of Participants Using Rescue Medication | Night | 72 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 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.
| 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 | 1.407 liters | Standard Error 0.0193 |
| Indacaterol 125 μg | Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose | 1.461 liters | Standard Error 0.0202 |
| Indacaterol 250 μg | Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose | 1.441 liters | Standard Error 0.0196 |
| Indacaterol 500 μg | Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose | 1.500 liters | Standard Error 0.0198 |
| Formoterol | Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose | 1.541 liters | Standard Error 0.0206 |
| Placebo | Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose | 1.315 liters | Standard Error 0.0208 |
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 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.
| 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 | 1.371 liters | Standard Error 0.0111 |
| 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 | 1.422 liters | Standard Error 0.0116 |
| 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 | 1.427 liters | Standard Error 0.0112 |
| 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 | 1.438 liters | Standard Error 0.0116 |
| 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 | 1.535 liters | Standard Error 0.0118 |
| 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 | 1.321 liters | Standard Error 0.0118 |
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 | 0.028 liters | Standard Error 0.0152 |
| Indacaterol 125 μg | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1 | 0.054 liters | Standard Error 0.0158 |
| Indacaterol 250 μg | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1 | 0.060 liters | Standard Error 0.0151 |
| Indacaterol 500 μg | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1 | 0.073 liters | Standard Error 0.0156 |
| Formoterol | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1 | 0.140 liters | Standard Error 0.016 |
| Placebo | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1 | -0.009 liters | Standard Error 0.016 |
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 14 [N=93, 86, 90, 89, 83, 82] | 91.3 minutes | Standard Deviation 81.2 |
| Indacaterol 62.5 μg | 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 |
| Indacaterol 125 μg | 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] | 105.6 minutes | Standard Deviation 82.53 |
| Indacaterol 125 μg | 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] | 84.4 minutes | Standard Deviation 77.74 |
| Indacaterol 250 μg | 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] | 104.7 minutes | Standard Deviation 75.96 |
| Indacaterol 250 μg | 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] | 101.4 minutes | Standard Deviation 83.44 |
| Indacaterol 500 μg | 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] | 116.4 minutes | Standard Deviation 85.03 |
| Indacaterol 500 μg | 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] | 105.3 minutes | Standard Deviation 81.85 |
| Formoterol | 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] | 115.0 minutes | Standard Deviation 81.59 |
| Formoterol | 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] | 89.1 minutes | Standard Deviation 72.91 |
| Placebo | 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] | 85.7 minutes | Standard Deviation 81.44 |
| Placebo | 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] | 68.0 minutes | Standard Deviation 70.38 |