Asthma
Conditions
Keywords
Asthma, Indacaterol, QAB149
Brief summary
This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of two different formulations of indacaterol maleate, both administered via the Concept1 device. The study aims to determine whether the novel formulation has a similar clinical profile as the established formulation.
Interventions
DRUG75 µg indacaterol maleate (LB)
75 µg indacaterol maleate lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
DRUG75 µg indacaterol maleate (PoS)
75 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.
DRUG37.5 µg indacaterol maleate (PoS)
37.5 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.
DRUGplacebo to indacaterol (LB)
Placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
DRUGplacebo to indacaterol (PoS)
Placebo to indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients with asthma * Aged 18 or above * Patients using inhaled corticosteroid (with or without long acting beta agonist) * Patients who demonstrate an increase in FEV1 after inhaling a short acting beta agonist
Exclusion criteria
* Asthma exacerbations in previous 6 months * COPD or other pulmonary disease * Excessive use of short acting beta agonists
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trough Forced Expiratory Volume in One Second (FEV1) After 7 Days of Treatment | Day 8 | Spirometry was performed according to internationally accepted standards at Day 8. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose.at Day 8. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak FEV1 at Day 1 and Day 7 | Day 1, Day 7 | Spirometry was performed according to internationally accepted standards at 0, 15 and 30 minutes; 1,2,3,4,8,12 hours on Day 1 and 23.16 and 23.75 hours on Day 2 after 1 day of treatment and on Day 7 and Day 8 following 7 days of treatment. Peak FEV1 was the maximum FEV1 post treatment. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline included as a covariate. |
| Time to Peak FEV1 at Day 1 and Day 7 | Day 1, Day 7 | Spirometry was performed according to internationally accepted standards. Time to the peak (maximum) FEV1 is recorded. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate. |
| FEV1 at Each Time-Point on Day 1 and Day 2 | Day 1, Day 2 | Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8, 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. |
| FEV1 at Each Time-Point on Day 7 and Day 8 | Day 7, Day 8 | Spirometry was conducted according to internationally accepted standards at 0, 15 and 30 minutes; 1,2,3,4,8,12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. |
| Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | Day 1, Day 2 | Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FVC is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. |
| Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | Day 7, Day 8 | Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. FVC is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. |
| FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | Day1, Day 2 | Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation. |
| FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | Day 7, Day 8 | Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2 after treatment. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation. |
| Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | Day 1, Day 2 | Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry. |
| Trough Forced Expiratory Volume in One Second (FEV1) After 1 Day of Treatment | Day 2 | Spirometry was performed according to internationally accepted standards at Day 2. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose at Day 2. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate. |
| Standardized FEV1 AUC Between Baseline (Pre-dose) and 4 Hour Post-dose (AUC0-4h) | Day 1, Day 7 | Spirometry was conducted according to internationally accepted standards at predose, 5, 15 and 30 minutes, 1, 2 and 4 hours post-dose on Day 1 and Day 7. The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 4 h post. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate. |
| Standardized FEV1 AUC Between Baseline (Pre-dose) and 12 Hour Post-dose (AUC0-12h) | Day 1, Day 7 | Spirometry was conducted according to internationally accepted standards at predose, 5 , 15 and 30 min, 1, 2, 4, 8 and 12 hours post-dose on Day 1 and Day 7. The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 12 h post. Analysis of covariance with treatment, period, sequence and subject nested within sequence as fixed effects and FEV1 period baseline as a covariate. |
| Peak Expiratory Flow Rate in the Morning in the Evening | Up to 101 days | PEFR was measured on all days from Screening Visit 2 to end of study visit: twice daily pre-dose (prior to Inhaled Corticosteroids) and approximately 12 hours post-dose (during the treatment period). Each subject was provided with a PEFR meter and recorded the PEFR readings in a daily diary. repeated measures. Analysis of covariance with treatment, period, sequence, day and treatment-day interaction as fixed effect and subject as a random effect and baseline PEFR as a covariate in the model. |
| Number of Puffs of Rescue Medicine | Up to 101 days | Salbutamol (100 µg/puff) was used as rescued medicine. The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient and was recorded in the patient diary from Baseline until Day 8 of Treatment Period 4. Analysis of covariance with treatment, period, sequence, and subject nested within sequence as fixed effect. |
| Number of Participants With Adverse Events as a Measure of Safety | Up to 101 days | Adverse event are defined as any unfavorable and unintended diagnosis, symptoms, sign (including an abnormal lab finding), syndrome or disease which either occurs during the study, having been absent at baseline, or if present at baseline appear to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization , cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards. Additional information about adverse events can be found in the Adverse Event section |
| Time to Reach Maximum Concentration (Tmax) After Drug Administration | Day1, Day 7 | — |
| Observed Maximum Concentration (Cmax) After Drug Administration | Day 1, Day 7 | — |
| Area Under the Curve Pre-dose to 24 Hour Post Dose (AUC0-24h) | Day 1, Day 7 | — |
| Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | Day 7, Day 8 | Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry. |
Countries
Germany, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants randomized to one of four treatment sequences. | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Treatment Period 1 | Adverse Event | 1 | 0 | 0 | 0 |
| Treatment Period 2 | Subject withdrew consent | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 45.8 Years STANDARD_DEVIATION 12.39 |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 14 / 34 | 16 / 31 | 17 / 33 | 9 / 33 |
| serious Total, serious adverse events | 0 / 34 | 0 / 31 | 0 / 33 | 1 / 33 |
Outcome results
Primary
Trough Forced Expiratory Volume in One Second (FEV1) After 7 Days of Treatment
Spirometry was performed according to internationally accepted standards at Day 8. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose.at Day 8. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.
Time frame: Day 8
Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 75 µg Indacaterol (LB) | Trough Forced Expiratory Volume in One Second (FEV1) After 7 Days of Treatment | 2.84 Liters | Standard Error 0.03 |
| 75 µg Indacaterol (PoS) | Trough Forced Expiratory Volume in One Second (FEV1) After 7 Days of Treatment | 2.83 Liters | Standard Error 0.03 |
| 37.5 µg Indacaterol (PoS) | Trough Forced Expiratory Volume in One Second (FEV1) After 7 Days of Treatment | 2.80 Liters | Standard Error 0.03 |
| Placebo | Trough Forced Expiratory Volume in One Second (FEV1) After 7 Days of Treatment | 2.64 Liters | Standard Error 0.03 |
Secondary
Area Under the Curve Pre-dose to 24 Hour Post Dose (AUC0-24h)
Time frame: Day 1, Day 7
Population: PK Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 75 µg Indacaterol (LB) | Area Under the Curve Pre-dose to 24 Hour Post Dose (AUC0-24h) | Day 1 (n=30,30,27) | 501 hour*pg/mL | Standard Deviation 149 |
| 75 µg Indacaterol (LB) | Area Under the Curve Pre-dose to 24 Hour Post Dose (AUC0-24h) | Day 7 (n=33,31,31) | 1110 hour*pg/mL | Standard Deviation 273 |
| 75 µg Indacaterol (PoS) | Area Under the Curve Pre-dose to 24 Hour Post Dose (AUC0-24h) | Day 1 (n=30,30,27) | 802 hour*pg/mL | Standard Deviation 308 |
| 75 µg Indacaterol (PoS) | Area Under the Curve Pre-dose to 24 Hour Post Dose (AUC0-24h) | Day 7 (n=33,31,31) | 1770 hour*pg/mL | Standard Deviation 522 |
| 37.5 µg Indacaterol (PoS) | Area Under the Curve Pre-dose to 24 Hour Post Dose (AUC0-24h) | Day 1 (n=30,30,27) | 451 hour*pg/mL | Standard Deviation 134 |
| 37.5 µg Indacaterol (PoS) | Area Under the Curve Pre-dose to 24 Hour Post Dose (AUC0-24h) | Day 7 (n=33,31,31) | 952 hour*pg/mL | Standard Deviation 287 |
Secondary
FEV1 at Each Time-Point on Day 1 and Day 2
Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8, 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Time frame: Day 1, Day 2
Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 75 µg Indacaterol (LB) | FEV1 at Each Time-Point on Day 1 and Day 2 | 2 hours post-dose | 2.98 Liters | Standard Deviation 0.73 |
| 75 µg Indacaterol (LB) | FEV1 at Each Time-Point on Day 1 and Day 2 | 1 hour post-dose | 2.89 Liters | Standard Deviation 0.76 |
| 75 µg Indacaterol (LB) | FEV1 at Each Time-Point on Day 1 and Day 2 | 4 hours post-dose | 2.99 Liters | Standard Deviation 0.73 |
| 75 µg Indacaterol (LB) | FEV1 at Each Time-Point on Day 1 and Day 2 | 23.16 hours post-dose | 2.81 Liters | Standard Deviation 0.74 |
| 75 µg Indacaterol (LB) | FEV1 at Each Time-Point on Day 1 and Day 2 | 30 minutes post-dose | 2.86 Liters | Standard Deviation 0.76 |
| 75 µg Indacaterol (LB) | FEV1 at Each Time-Point on Day 1 and Day 2 | 23.75 hours post-dose | 2.89 Liters | Standard Deviation 0.75 |
| 75 µg Indacaterol (LB) | FEV1 at Each Time-Point on Day 1 and Day 2 | 3 hours post-dose | 2.98 Liters | Standard Deviation 0.76 |
| 75 µg Indacaterol (LB) | FEV1 at Each Time-Point on Day 1 and Day 2 | 0 minutes post-dose | 2.61 Liters | Standard Deviation 0.71 |
| 75 µg Indacaterol (LB) | FEV1 at Each Time-Point on Day 1 and Day 2 | 12 hours post-dose | 2.74 Liters | Standard Deviation 0.65 |
| 75 µg Indacaterol (LB) | FEV1 at Each Time-Point on Day 1 and Day 2 | 8 hours post-dose | 2.80 Liters | Standard Deviation 0.6 |
| 75 µg Indacaterol (LB) | FEV1 at Each Time-Point on Day 1 and Day 2 | 5 minutes post-dose | 2.85 Liters | Standard Deviation 0.76 |
| 75 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 1 and Day 2 | 2 hours post-dose | 3.06 Liters | Standard Deviation 0.81 |
| 75 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 1 and Day 2 | 5 minutes post-dose | 2.97 Liters | Standard Deviation 0.8 |
| 75 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 1 and Day 2 | 8 hours post-dose | 2.99 Liters | Standard Deviation 0.83 |
| 75 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 1 and Day 2 | 30 minutes post-dose | 2.96 Liters | Standard Deviation 0.75 |
| 75 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 1 and Day 2 | 4 hours post-dose | 3.07 Liters | Standard Deviation 0.81 |
| 75 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 1 and Day 2 | 1 hour post-dose | 3.03 Liters | Standard Deviation 0.8 |
| 75 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 1 and Day 2 | 12 hours post-dose | 2.92 Liters | Standard Deviation 0.79 |
| 75 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 1 and Day 2 | 3 hours post-dose | 3.09 Liters | Standard Deviation 0.8 |
| 75 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 1 and Day 2 | 23.16 hours post-dose | 2.85 Liters | Standard Deviation 0.77 |
| 75 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 1 and Day 2 | 23.75 hours post-dose | 2.88 Liters | Standard Deviation 0.8 |
| 75 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 1 and Day 2 | 0 minutes post-dose | 2.65 Liters | Standard Deviation 0.7 |
| 37.5 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 1 and Day 2 | 23.75 hours post-dose | 2.85 Liters | Standard Deviation 0.72 |
| 37.5 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 1 and Day 2 | 3 hours post-dose | 3.05 Liters | Standard Deviation 0.75 |
| 37.5 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 1 and Day 2 | 4 hours post-dose | 3.00 Liters | Standard Deviation 0.75 |
| 37.5 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 1 and Day 2 | 8 hours post-dose | 2.89 Liters | Standard Deviation 0.79 |
| 37.5 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 1 and Day 2 | 12 hours post-dose | 2.85 Liters | Standard Deviation 0.79 |
| 37.5 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 1 and Day 2 | 23.16 hours post-dose | 2.83 Liters | Standard Deviation 0.76 |
| 37.5 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 1 and Day 2 | 0 minutes post-dose | 2.68 Liters | Standard Deviation 0.68 |
| 37.5 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 1 and Day 2 | 5 minutes post-dose | 2.90 Liters | Standard Deviation 0.75 |
| 37.5 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 1 and Day 2 | 30 minutes post-dose | 2.93 Liters | Standard Deviation 0.73 |
| 37.5 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 1 and Day 2 | 1 hour post-dose | 2.95 Liters | Standard Deviation 0.75 |
| 37.5 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 1 and Day 2 | 2 hours post-dose | 3.02 Liters | Standard Deviation 0.74 |
| Placebo | FEV1 at Each Time-Point on Day 1 and Day 2 | 30 minutes post-dose | 2.70 Liters | Standard Deviation 0.71 |
| Placebo | FEV1 at Each Time-Point on Day 1 and Day 2 | 0 minutes post-dose | 2.67 Liters | Standard Deviation 0.69 |
| Placebo | FEV1 at Each Time-Point on Day 1 and Day 2 | 5 minutes post-dose | 2.66 Liters | Standard Deviation 0.69 |
| Placebo | FEV1 at Each Time-Point on Day 1 and Day 2 | 2 hours post-dose | 2.82 Liters | Standard Deviation 0.68 |
| Placebo | FEV1 at Each Time-Point on Day 1 and Day 2 | 23.75 hours post-dose | 2.68 Liters | Standard Deviation 0.69 |
| Placebo | FEV1 at Each Time-Point on Day 1 and Day 2 | 3 hours post-dose | 2.80 Liters | Standard Deviation 0.69 |
| Placebo | FEV1 at Each Time-Point on Day 1 and Day 2 | 12 hours post-dose | 2.71 Liters | Standard Deviation 0.67 |
| Placebo | FEV1 at Each Time-Point on Day 1 and Day 2 | 23.16 hours post-dose | 2.59 Liters | Standard Deviation 0.69 |
| Placebo | FEV1 at Each Time-Point on Day 1 and Day 2 | 8 hours post-dose | 2.70 Liters | Standard Deviation 0.68 |
| Placebo | FEV1 at Each Time-Point on Day 1 and Day 2 | 4 hours post-dose | 2.77 Liters | Standard Deviation 0.67 |
| Placebo | FEV1 at Each Time-Point on Day 1 and Day 2 | 1 hour post-dose | 2.73 Liters | Standard Deviation 0.72 |
Secondary
FEV1 at Each Time-Point on Day 7 and Day 8
Spirometry was conducted according to internationally accepted standards at 0, 15 and 30 minutes; 1,2,3,4,8,12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Time frame: Day 7, Day 8
Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 75 µg Indacaterol (LB) | FEV1 at Each Time-Point on Day 7 and Day 8 | 30 minutes post-dose | 2.91 Liters | Standard Deviation 0.79 |
| 75 µg Indacaterol (LB) | FEV1 at Each Time-Point on Day 7 and Day 8 | 1 hour post-dose | 2.94 Liters | Standard Deviation 0.75 |
| 75 µg Indacaterol (LB) | FEV1 at Each Time-Point on Day 7 and Day 8 | 15 minutes post-dose | 2.87 Liters | Standard Deviation 0.8 |
| 75 µg Indacaterol (LB) | FEV1 at Each Time-Point on Day 7 and Day 8 | 23.16 hours post-dose | 2.79 Liters | Standard Deviation 0.71 |
| 75 µg Indacaterol (LB) | FEV1 at Each Time-Point on Day 7 and Day 8 | 8 hours post-dose | 2.82 Liters | Standard Deviation 0.64 |
| 75 µg Indacaterol (LB) | FEV1 at Each Time-Point on Day 7 and Day 8 | 0 minutes post-dose | 2.80 Liters | Standard Deviation 0.77 |
| 75 µg Indacaterol (LB) | FEV1 at Each Time-Point on Day 7 and Day 8 | 3 hours post-dose | 2.99 Liters | Standard Deviation 0.74 |
| 75 µg Indacaterol (LB) | FEV1 at Each Time-Point on Day 7 and Day 8 | 4 hours post-dose | 2.98 Liters | Standard Deviation 0.75 |
| 75 µg Indacaterol (LB) | FEV1 at Each Time-Point on Day 7 and Day 8 | 23.75 hours post-dose | 2.89 Liters | Standard Deviation 0.72 |
| 75 µg Indacaterol (LB) | FEV1 at Each Time-Point on Day 7 and Day 8 | 2 hours post-dose | 2.99 Liters | Standard Deviation 0.76 |
| 75 µg Indacaterol (LB) | FEV1 at Each Time-Point on Day 7 and Day 8 | 12 hours post-dose | 2.76 Liters | Standard Deviation 0.66 |
| 75 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 7 and Day 8 | 3 hours post-dose | 2.99 Liters | Standard Deviation 0.75 |
| 75 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 7 and Day 8 | 4 hours post-dose | 2.98 Liters | Standard Deviation 0.73 |
| 75 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 7 and Day 8 | 0 minutes post-dose | 2.79 Liters | Standard Deviation 0.72 |
| 75 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 7 and Day 8 | 15 minutes post-dose | 2.88 Liters | Standard Deviation 0.77 |
| 75 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 7 and Day 8 | 30 minutes post-dose | 2.92 Liters | Standard Deviation 0.76 |
| 75 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 7 and Day 8 | 1 hour post-dose | 2.96 Liters | Standard Deviation 0.77 |
| 75 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 7 and Day 8 | 2 hours post-dose | 3.00 Liters | Standard Deviation 0.72 |
| 75 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 7 and Day 8 | 8 hours post-dose | 2.88 Liters | Standard Deviation 0.77 |
| 75 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 7 and Day 8 | 12 hours post-dose | 2.80 Liters | Standard Deviation 0.78 |
| 75 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 7 and Day 8 | 23.16 hours post-dose | 2.79 Liters | Standard Deviation 0.77 |
| 75 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 7 and Day 8 | 23.75 hours post-dose | 2.87 Liters | Standard Deviation 0.76 |
| 37.5 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 7 and Day 8 | 2 hours post-dose | 3.00 Liters | Standard Deviation 0.73 |
| 37.5 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 7 and Day 8 | 12 hours post-dose | 2.82 Liters | Standard Deviation 0.76 |
| 37.5 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 7 and Day 8 | 3 hours post-dose | 3.06 Liters | Standard Deviation 0.75 |
| 37.5 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 7 and Day 8 | 4 hours post-dose | 3.02 Liters | Standard Deviation 0.7 |
| 37.5 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 7 and Day 8 | 1 hour post-dose | 2.97 Liters | Standard Deviation 0.76 |
| 37.5 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 7 and Day 8 | 15 minutes post-dose | 2.92 Liters | Standard Deviation 0.76 |
| 37.5 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 7 and Day 8 | 23.75 hours post-dose | 2.87 Liters | Standard Deviation 0.74 |
| 37.5 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 7 and Day 8 | 30 minutes post-dose | 2.94 Liters | Standard Deviation 0.77 |
| 37.5 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 7 and Day 8 | 8 hours post-dose | 2.89 Liters | Standard Deviation 0.75 |
| 37.5 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 7 and Day 8 | 0 minutes post-dose | 2.85 Liters | Standard Deviation 0.73 |
| 37.5 µg Indacaterol (PoS) | FEV1 at Each Time-Point on Day 7 and Day 8 | 23.16 hours post-dose | 2.79 Liters | Standard Deviation 0.79 |
| Placebo | FEV1 at Each Time-Point on Day 7 and Day 8 | 23.75 hours post-dose | 2.74 Liters | Standard Deviation 0.68 |
| Placebo | FEV1 at Each Time-Point on Day 7 and Day 8 | 23.16 hours post-dose | 2.64 Liters | Standard Deviation 0.68 |
| Placebo | FEV1 at Each Time-Point on Day 7 and Day 8 | 2 hours post-dose | 2.79 Liters | Standard Deviation 0.72 |
| Placebo | FEV1 at Each Time-Point on Day 7 and Day 8 | 3 hours post-dose | 2.79 Liters | Standard Deviation 0.72 |
| Placebo | FEV1 at Each Time-Point on Day 7 and Day 8 | 4 hours post-dose | 2.78 Liters | Standard Deviation 0.7 |
| Placebo | FEV1 at Each Time-Point on Day 7 and Day 8 | 1 hour post-dose | 2.72 Liters | Standard Deviation 0.7 |
| Placebo | FEV1 at Each Time-Point on Day 7 and Day 8 | 15 minutes post-dose | 2.65 Liters | Standard Deviation 0.72 |
| Placebo | FEV1 at Each Time-Point on Day 7 and Day 8 | 8 hours post-dose | 2.76 Liters | Standard Deviation 0.65 |
| Placebo | FEV1 at Each Time-Point on Day 7 and Day 8 | 12 hours post-dose | 2.65 Liters | Standard Deviation 0.7 |
| Placebo | FEV1 at Each Time-Point on Day 7 and Day 8 | 0 minutes post-dose | 2.63 Liters | Standard Deviation 0.67 |
| Placebo | FEV1 at Each Time-Point on Day 7 and Day 8 | 30 minutes post-dose | 2.64 Liters | Standard Deviation 0.72 |
Secondary
FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2
Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation.
Time frame: Day1, Day 2
Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 75 µg Indacaterol (LB) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 12 hours post-dose | 0.66 Ratio | Standard Deviation 0.08 |
| 75 µg Indacaterol (LB) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 1 hour post-dose | 0.67 Ratio | Standard Deviation 0.07 |
| 75 µg Indacaterol (LB) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 3 hours post-dose | 0.68 Ratio | Standard Deviation 0.08 |
| 75 µg Indacaterol (LB) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 8 hours post-dose | 0.67 Ratio | Standard Deviation 0.07 |
| 75 µg Indacaterol (LB) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 4 hours post-dose | 0.68 Ratio | Standard Deviation 0.08 |
| 75 µg Indacaterol (LB) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 23.75 hours post-dose | 0.66 Ratio | Standard Deviation 0.08 |
| 75 µg Indacaterol (LB) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 23.16 hours post-dose | 0.65 Ratio | Standard Deviation 0.09 |
| 75 µg Indacaterol (LB) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 2 hours post-dose | 0.68 Ratio | Standard Deviation 0.08 |
| 75 µg Indacaterol (LB) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 0 minutes post-dose | 0.63 Ratio | Standard Deviation 0.08 |
| 75 µg Indacaterol (LB) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 15 minutes post-dose | 0.67 Ratio | Standard Deviation 0.08 |
| 75 µg Indacaterol (LB) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 30 minutes post-dose | 0.67 Ratio | Standard Deviation 0.07 |
| 75 µg Indacaterol (PoS) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 12 hours post-dose | 0.66 Ratio | Standard Deviation 0.07 |
| 75 µg Indacaterol (PoS) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 15 minutes post-dose | 0.66 Ratio | Standard Deviation 0.07 |
| 75 µg Indacaterol (PoS) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 1 hour post-dose | 0.67 Ratio | Standard Deviation 0.07 |
| 75 µg Indacaterol (PoS) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 23.16 hours post-dose | 0.64 Ratio | Standard Deviation 0.08 |
| 75 µg Indacaterol (PoS) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 8 hours post-dose | 0.66 Ratio | Standard Deviation 0.07 |
| 75 µg Indacaterol (PoS) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 23.75 hours post-dose | 0.65 Ratio | Standard Deviation 0.08 |
| 75 µg Indacaterol (PoS) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 0 minutes post-dose | 0.62 Ratio | Standard Deviation 0.08 |
| 75 µg Indacaterol (PoS) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 4 hours post-dose | 0.67 Ratio | Standard Deviation 0.07 |
| 75 µg Indacaterol (PoS) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 3 hours post-dose | 0.68 Ratio | Standard Deviation 0.07 |
| 75 µg Indacaterol (PoS) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 30 minutes post-dose | 0.66 Ratio | Standard Deviation 0.07 |
| 75 µg Indacaterol (PoS) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 2 hours post-dose | 0.67 Ratio | Standard Deviation 0.07 |
| 37.5 µg Indacaterol (PoS) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 4 hours post-dose | 0.68 Ratio | Standard Deviation 0.08 |
| 37.5 µg Indacaterol (PoS) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 2 hours post-dose | 0.68 Ratio | Standard Deviation 0.08 |
| 37.5 µg Indacaterol (PoS) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 3 hours post-dose | 0.69 Ratio | Standard Deviation 0.08 |
| 37.5 µg Indacaterol (PoS) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 23.75 hours post-dose | 0.66 Ratio | Standard Deviation 0.08 |
| 37.5 µg Indacaterol (PoS) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 0 minutes post-dose | 0.64 Ratio | Standard Deviation 0.09 |
| 37.5 µg Indacaterol (PoS) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 15 minutes post-dose | 0.67 Ratio | Standard Deviation 0.09 |
| 37.5 µg Indacaterol (PoS) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 30 minutes post-dose | 0.67 Ratio | Standard Deviation 0.08 |
| 37.5 µg Indacaterol (PoS) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 1 hour post-dose | 0.68 Ratio | Standard Deviation 0.08 |
| 37.5 µg Indacaterol (PoS) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 8 hours post-dose | 0.67 Ratio | Standard Deviation 0.08 |
| 37.5 µg Indacaterol (PoS) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 12 hours post-dose | 0.66 Ratio | Standard Deviation 0.08 |
| 37.5 µg Indacaterol (PoS) | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 23.16 hours post-dose | 0.66 Ratio | Standard Deviation 0.09 |
| Placebo | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 23.16 hours post-dose | 0.62 Ratio | Standard Deviation 0.09 |
| Placebo | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 8 hours post-dose | 0.64 Ratio | Standard Deviation 0.07 |
| Placebo | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 30 minutes post-dose | 0.65 Ratio | Standard Deviation 0.09 |
| Placebo | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 15 minutes post-dose | 0.63 Ratio | Standard Deviation 0.09 |
| Placebo | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 0 minutes post-dose | 0.63 Ratio | Standard Deviation 0.09 |
| Placebo | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 12 hours post-dose | 0.64 Ratio | Standard Deviation 0.08 |
| Placebo | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 23.75 hours post-dose | 0.63 Ratio | Standard Deviation 0.08 |
| Placebo | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 2 hours post-dose | 0.65 Ratio | Standard Deviation 0.08 |
| Placebo | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 4 hours post-dose | 0.65 Ratio | Standard Deviation 0.08 |
| Placebo | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 3 hours post-dose | 0.65 Ratio | Standard Deviation 0.08 |
| Placebo | FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 | 1 hour post-dose | 0.64 Ratio | Standard Deviation 0.08 |
Secondary
FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8
Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2 after treatment. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation.
Time frame: Day 7, Day 8
Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 75 µg Indacaterol (LB) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 4 hours post-dose | 0.68 Ratio | Standard Deviation 0.07 |
| 75 µg Indacaterol (LB) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 0 minutes post-dose | 0.65 Ratio | Standard Deviation 0.08 |
| 75 µg Indacaterol (LB) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 8 hours post-dose | 0.66 Ratio | Standard Deviation 0.07 |
| 75 µg Indacaterol (LB) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 15 minutes post-dose | 0.66 Ratio | Standard Deviation 0.08 |
| 75 µg Indacaterol (LB) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 23.16 hours post-dose | 0.64 Ratio | Standard Deviation 0.67 |
| 75 µg Indacaterol (LB) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 23.75 hours post-dose | 0.65 Ratio | Standard Deviation 0.72 |
| 75 µg Indacaterol (LB) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 3 hours post-dose | 0.68 Ratio | Standard Deviation 0.07 |
| 75 µg Indacaterol (LB) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 1 hour post-dose | 0.67 Ratio | Standard Deviation 0.07 |
| 75 µg Indacaterol (LB) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 30 minutes post-dose | 0.67 Ratio | Standard Deviation 0.08 |
| 75 µg Indacaterol (LB) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 12 hours post-dose | 0.66 Ratio | Standard Deviation 0.08 |
| 75 µg Indacaterol (LB) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 2 hours post-dose | 0.68 Ratio | Standard Deviation 0.07 |
| 75 µg Indacaterol (PoS) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 1 hour post-dose | 0.68 Ratio | Standard Deviation 0.07 |
| 75 µg Indacaterol (PoS) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 8 hours post-dose | 0.67 Ratio | Standard Deviation 0.07 |
| 75 µg Indacaterol (PoS) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 3 hours post-dose | 0.68 Ratio | Standard Deviation 0.07 |
| 75 µg Indacaterol (PoS) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 0 minutes post-dose | 0.65 Ratio | Standard Deviation 0.07 |
| 75 µg Indacaterol (PoS) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 4 hours post-dose | 0.68 Ratio | Standard Deviation 0.07 |
| 75 µg Indacaterol (PoS) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 23.75 hours post-dose | 0.66 Ratio | Standard Deviation 0.07 |
| 75 µg Indacaterol (PoS) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 2 hours post-dose | 0.68 Ratio | Standard Deviation 0.06 |
| 75 µg Indacaterol (PoS) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 23.16 hours post-dose | 0.65 Ratio | Standard Deviation 0.08 |
| 75 µg Indacaterol (PoS) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 12 hours post-dose | 0.66 Ratio | Standard Deviation 0.07 |
| 75 µg Indacaterol (PoS) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 15 minutes post-dose | 0.66 Ratio | Standard Deviation 0.07 |
| 75 µg Indacaterol (PoS) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 30 minutes post-dose | 0.67 Ratio | Standard Deviation 0.06 |
| 37.5 µg Indacaterol (PoS) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 23.75 hours post-dose | 0.66 Ratio | Standard Deviation 0.08 |
| 37.5 µg Indacaterol (PoS) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 30 minutes post-dose | 0.67 Ratio | Standard Deviation 0.07 |
| 37.5 µg Indacaterol (PoS) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 2 hours post-dose | 0.68 Ratio | Standard Deviation 0.07 |
| 37.5 µg Indacaterol (PoS) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 23.16 hours post-dose | 0.65 Ratio | Standard Deviation 0.08 |
| 37.5 µg Indacaterol (PoS) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 0 minutes post-dose | 0.65 Ratio | Standard Deviation 0.08 |
| 37.5 µg Indacaterol (PoS) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 15 minutes post-dose | 0.67 Ratio | Standard Deviation 0.07 |
| 37.5 µg Indacaterol (PoS) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 1 hour post-dose | 0.67 Ratio | Standard Deviation 0.07 |
| 37.5 µg Indacaterol (PoS) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 3 hours post-dose | 0.69 Ratio | Standard Deviation 0.08 |
| 37.5 µg Indacaterol (PoS) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 4 hours post-dose | 0.68 Ratio | Standard Deviation 0.07 |
| 37.5 µg Indacaterol (PoS) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 8 hours post-dose | 0.67 Ratio | Standard Deviation 0.08 |
| 37.5 µg Indacaterol (PoS) | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 12 hours post-dose | 0.66 Ratio | Standard Deviation 0.08 |
| Placebo | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 1 hour post-dose | 0.64 Ratio | Standard Deviation 0.08 |
| Placebo | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 30 minutes post-dose | 0.63 Ratio | Standard Deviation 0.09 |
| Placebo | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 8 hours post-dose | 0.64 Ratio | Standard Deviation 0.08 |
| Placebo | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 15 minutes post-dose | 0.63 Ratio | Standard Deviation 0.08 |
| Placebo | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 23.75 hours post-dose | 0.63 Ratio | Standard Deviation 0.09 |
| Placebo | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 0 minutes post-dose | 0.62 Ratio | Standard Deviation 0.08 |
| Placebo | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 12 hours post-dose | 0.63 Ratio | Standard Deviation 0.08 |
| Placebo | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 23.16 hours post-dose | 0.62 Ratio | Standard Deviation 0.09 |
| Placebo | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 3 hours post-dose | 0.65 Ratio | Standard Deviation 0.09 |
| Placebo | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 4 hours post-dose | 0.64 Ratio | Standard Deviation 0.08 |
| Placebo | FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 | 2 hours post-dose | 0.64 Ratio | Standard Deviation 0.08 |
Secondary
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2
Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.
Time frame: Day 1, Day 2
Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 75 µg Indacaterol (LB) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 23.75 hours post-dose | 1.77 Liters/second | Standard Deviation 0.74 |
| 75 µg Indacaterol (LB) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 23.16 hours post-dose | 1.70 Liters/second | Standard Deviation 0.77 |
| 75 µg Indacaterol (LB) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 8 hours post-dose | 1.71 Liters/second | Standard Deviation 0.69 |
| 75 µg Indacaterol (LB) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 12 hours post-dose | 1.63 Liters/second | Standard Deviation 0.65 |
| 75 µg Indacaterol (LB) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 4 hours post-dose | 1.94 Liters/second | Standard Deviation 0.82 |
| 75 µg Indacaterol (LB) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 1 hour post-dose | 1.79 Liters/second | Standard Deviation 0.77 |
| 75 µg Indacaterol (LB) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 30 minutes post-dose | 1.80 Liters/second | Standard Deviation 0.8 |
| 75 µg Indacaterol (LB) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 3 hours post-dose | 1.89 Liters/second | Standard Deviation 0.81 |
| 75 µg Indacaterol (LB) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 15 minutes post-dose | 1.78 Liters/second | Standard Deviation 0.75 |
| 75 µg Indacaterol (LB) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 2 hours post-dose | 1.90 Liters/second | Standard Deviation 0.8 |
| 75 µg Indacaterol (LB) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 0 minutes post-dose | 1.55 Liters/second | Standard Deviation 0.68 |
| 75 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 3 hours post-dose | 2.01 Liters/second | Standard Deviation 0.83 |
| 75 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 30 minutes post-dose | 1.82 Liters/second | Standard Deviation 0.77 |
| 75 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 1 hour post-dose | 1.95 Liters/second | Standard Deviation 0.85 |
| 75 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 8 hours post-dose | 1.83 Liters/second | Standard Deviation 0.84 |
| 75 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 23.16 hours post-dose | 1.68 Liters/second | Standard Deviation 0.75 |
| 75 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 23.75 hours post-dose | 1.76 Liters/second | Standard Deviation 0.77 |
| 75 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 0 minutes post-dose | 1.52 Liters/second | Standard Deviation 0.7 |
| 75 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 15 minutes post-dose | 1.81 Liters/second | Standard Deviation 0.79 |
| 75 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 2 hours post-dose | 1.93 Liters/second | Standard Deviation 0.84 |
| 75 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 4 hours post-dose | 1.94 Liters/second | Standard Deviation 0.85 |
| 75 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 12 hours post-dose | 1.77 Liters/second | Standard Deviation 0.78 |
| 37.5 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 23.16 hours post-dose | 1.78 Liters/second | Standard Deviation 0.8 |
| 37.5 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 3 hours post-dose | 1.99 Liters/second | Standard Deviation 0.85 |
| 37.5 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 23.75 hours post-dose | 1.75 Liters/second | Standard Deviation 0.71 |
| 37.5 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 15 minutes post-dose | 1.82 Liters/second | Standard Deviation 0.77 |
| 37.5 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 0 minutes post-dose | 1.54 Liters/second | Standard Deviation 0.67 |
| 37.5 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 30 minutes post-dose | 1.84 Liters/second | Standard Deviation 0.73 |
| 37.5 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 4 hours post-dose | 1.92 Liters/second | Standard Deviation 0.8 |
| 37.5 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 2 hours post-dose | 1.92 Liters/second | Standard Deviation 0.79 |
| 37.5 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 8 hours post-dose | 1.79 Liters/second | Standard Deviation 0.81 |
| 37.5 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 12 hours post-dose | 1.76 Liters/second | Standard Deviation 0.83 |
| 37.5 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 1 hour post-dose | 1.89 Liters/second | Standard Deviation 0.75 |
| Placebo | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 8 hours post-dose | 1.59 Liters/second | Standard Deviation 0.66 |
| Placebo | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 23.16 hours post-dose | 1.51 Liters/second | Standard Deviation 0.7 |
| Placebo | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 3 hours post-dose | 1.68 Liters/second | Standard Deviation 0.77 |
| Placebo | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 12 hours post-dose | 1.61 Liters/second | Standard Deviation 0.69 |
| Placebo | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 23.75 hours post-dose | 1.56 Liters/second | Standard Deviation 0.71 |
| Placebo | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 2 hours post-dose | 1.68 Liters/second | Standard Deviation 0.74 |
| Placebo | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 15 minutes post-dose | 1.54 Liters/second | Standard Deviation 0.72 |
| Placebo | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 30 minutes post-dose | 1.61 Liters/second | Standard Deviation 0.74 |
| Placebo | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 4 hours post-dose | 1.65 Liters/second | Standard Deviation 0.7 |
| Placebo | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 0 minutes post-dose | 1.56 Liters/second | Standard Deviation 0.71 |
| Placebo | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 | 1 hour post-dose | 1.59 Liters/second | Standard Deviation 0.73 |
Secondary
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8
Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.
Time frame: Day 7, Day 8
Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 75 µg Indacaterol (LB) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 12 hours post-dose | 1.66 Liters/second | Standard Deviation 0.68 |
| 75 µg Indacaterol (LB) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 1 hour post-dose | 1.82 Liters/second | Standard Deviation 0.77 |
| 75 µg Indacaterol (LB) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 30 minutes post-dose | 1.80 Liters/second | Standard Deviation 0.79 |
| 75 µg Indacaterol (LB) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 15 minutes post-dose | 1.76 Liters/second | Standard Deviation 0.83 |
| 75 µg Indacaterol (LB) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 8 hours post-dose | 1.71 Liters/second | Standard Deviation 0.66 |
| 75 µg Indacaterol (LB) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 2 hours post-dose | 1.88 Liters/second | Standard Deviation 0.8 |
| 75 µg Indacaterol (LB) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 0 minutes post-dose | 1.70 Liters/second | Standard Deviation 0.75 |
| 75 µg Indacaterol (LB) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 3 hours post-dose | 1.91 Liters/second | Standard Deviation 0.8 |
| 75 µg Indacaterol (LB) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 23.16 hours post-dose | 1.66 Liters/second | Standard Deviation 0.67 |
| 75 µg Indacaterol (LB) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 4 hours post-dose | 1.90 Liters/second | Standard Deviation 0.82 |
| 75 µg Indacaterol (LB) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 23.75 hours post-dose | 1.74 Liters/second | Standard Deviation 0.72 |
| 75 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 4 hours post-dose | 1.88 Liters/second | Standard Deviation 0.82 |
| 75 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 8 hours post-dose | 1.80 Liters/second | Standard Deviation 0.82 |
| 75 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 0 minutes post-dose | 1.69 Liters/second | Standard Deviation 0.76 |
| 75 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 12 hours post-dose | 1.68 Liters/second | Standard Deviation 0.83 |
| 75 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 23.16 hours post-dose | 1.69 Liters/second | Standard Deviation 0.81 |
| 75 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 23.75 hours post-dose | 1.73 Liters/second | Standard Deviation 0.79 |
| 75 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 30 minutes post-dose | 1.80 Liters/second | Standard Deviation 0.82 |
| 75 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 2 hours post-dose | 1.89 Liters/second | Standard Deviation 0.77 |
| 75 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 1 hour post-dose | 1.89 Liters/second | Standard Deviation 0.84 |
| 75 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 3 hours post-dose | 1.88 Liters/second | Standard Deviation 0.81 |
| 75 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 15 minutes post-dose | 1.78 Liters/second | Standard Deviation 0.82 |
| 37.5 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 3 hours post-dose | 2.02 Liters/second | Standard Deviation 0.82 |
| 37.5 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 0 minutes post-dose | 1.71 Liters/second | Standard Deviation 0.78 |
| 37.5 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 15 minutes post-dose | 1.83 Liters/second | Standard Deviation 0.8 |
| 37.5 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 30 minutes post-dose | 1.83 Liters/second | Standard Deviation 0.81 |
| 37.5 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 1 hour post-dose | 1.87 Liters/second | Standard Deviation 0.8 |
| 37.5 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 4 hours post-dose | 1.93 Liters/second | Standard Deviation 0.83 |
| 37.5 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 8 hours post-dose | 1.81 Liters/second | Standard Deviation 0.82 |
| 37.5 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 12 hours post-dose | 1.76 Liters/second | Standard Deviation 0.83 |
| 37.5 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 23.16 hours post-dose | 1.68 Liters/second | Standard Deviation 0.84 |
| 37.5 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 23.75 hours post-dose | 1.79 Liters/second | Standard Deviation 0.76 |
| 37.5 µg Indacaterol (PoS) | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 2 hours post-dose | 1.91 Liters/second | Standard Deviation 0.82 |
| Placebo | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 2 hours post-dose | 1.64 Liters/second | Standard Deviation 0.72 |
| Placebo | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 3 hours post-dose | 1.69 Liters/second | Standard Deviation 0.7 |
| Placebo | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 4 hours post-dose | 1.65 Liters/second | Standard Deviation 0.73 |
| Placebo | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 1 hour post-dose | 1.61 Liters/second | Standard Deviation 0.69 |
| Placebo | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 8 hours post-dose | 1.64 Liters/second | Standard Deviation 0.67 |
| Placebo | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 30 minutes post-dose | 1.57 Liters/second | Standard Deviation 0.72 |
| Placebo | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 12 hours post-dose | 1.56 Liters/second | Standard Deviation 0.72 |
| Placebo | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 15 minutes post-dose | 1.54 Liters/second | Standard Deviation 0.73 |
| Placebo | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 23.16 hours post-dose | 1.52 Liters/second | Standard Deviation 0.64 |
| Placebo | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 0 minutes post-dose | 1.51 Liters/second | Standard Deviation 0.67 |
| Placebo | Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 | 23.75 hours post-dose | 1.62 Liters/second | Standard Deviation 0.72 |
Secondary
Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2
Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FVC is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.
Time frame: Day 1, Day 2
Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 75 µg Indacaterol (LB) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 0 minutes post-dose | 4.11 Liters | Standard Deviation 1.02 |
| 75 µg Indacaterol (LB) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 1 hour post-dose | 4.33 Liters | Standard Deviation 1.06 |
| 75 µg Indacaterol (LB) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 2 hours post-dose | 4.39 Liters | Standard Deviation 0.99 |
| 75 µg Indacaterol (LB) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 15 minutes post-dose | 4.29 Liters | Standard Deviation 1.07 |
| 75 µg Indacaterol (LB) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 12 hours post-dose | 4.16 Liters | Standard Deviation 0.93 |
| 75 µg Indacaterol (LB) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 3 hours post-dose | 4.38 Liters | Standard Deviation 1.04 |
| 75 µg Indacaterol (LB) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 23.75 hours post-dose | 4.41 Liters | Standard Deviation 1.06 |
| 75 µg Indacaterol (LB) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 30 minutes post-dose | 4.29 Liters | Standard Deviation 1.03 |
| 75 µg Indacaterol (LB) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 8 hours post-dose | 4.20 Liters | Standard Deviation 0.86 |
| 75 µg Indacaterol (LB) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 4 hours post-dose | 4.39 Liters | Standard Deviation 1.01 |
| 75 µg Indacaterol (LB) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 23.16 hours post-dose | 4.34 Liters | Standard Deviation 1.06 |
| 75 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 23.16 hours post-dose | 4.44 Liters | Standard Deviation 1.08 |
| 75 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 0 minutes post-dose | 4.30 Liters | Standard Deviation 0.98 |
| 75 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 15 minutes post-dose | 4.52 Liters | Standard Deviation 1.1 |
| 75 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 30 minutes post-dose | 4.47 Liters | Standard Deviation 1.02 |
| 75 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 3 hours post-dose | 4.52 Liters | Standard Deviation 1.05 |
| 75 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 2 hours post-dose | 4.54 Liters | Standard Deviation 1.07 |
| 75 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 23.75 hours post-dose | 4.41 Liters | Standard Deviation 1.1 |
| 75 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 12 hours post-dose | 4.42 Liters | Standard Deviation 1.05 |
| 75 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 1 hour post-dose | 4.49 Liters | Standard Deviation 1.05 |
| 75 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 8 hours post-dose | 4.51 Liters | Standard Deviation 1.09 |
| 75 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 4 hours post-dose | 4.54 Liters | Standard Deviation 1.06 |
| 37.5 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 0 minutes post-dose | 4.23 Liters | Standard Deviation 1.03 |
| 37.5 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 30 minutes post-dose | 4.39 Liters | Standard Deviation 1.01 |
| 37.5 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 1 hour post-dose | 4.38 Liters | Standard Deviation 1.06 |
| 37.5 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 3 hours post-dose | 4.44 Liters | Standard Deviation 0.98 |
| 37.5 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 4 hours post-dose | 4.40 Liters | Standard Deviation 1.01 |
| 37.5 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 15 minutes post-dose | 4.34 Liters | Standard Deviation 1.04 |
| 37.5 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 2 hours post-dose | 4.45 Liters | Standard Deviation 1.02 |
| 37.5 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 8 hours post-dose | 4.35 Liters | Standard Deviation 1.07 |
| 37.5 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 12 hours post-dose | 4.29 Liters | Standard Deviation 1.04 |
| 37.5 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 23.16 hours post-dose | 4.31 Liters | Standard Deviation 1.08 |
| 37.5 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 23.75 hours post-dose | 4.36 Liters | Standard Deviation 1.08 |
| Placebo | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 3 hours post-dose | 4.33 Liters | Standard Deviation 0.98 |
| Placebo | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 23.16 hours post-dose | 4.21 Liters | Standard Deviation 0.99 |
| Placebo | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 8 hours post-dose | 4.21 Liters | Standard Deviation 1.01 |
| Placebo | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 2 hours post-dose | 4.36 Liters | Standard Deviation 0.97 |
| Placebo | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 30 minutes post-dose | 4.18 Liters | Standard Deviation 1.07 |
| Placebo | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 15 minutes post-dose | 4.25 Liters | Standard Deviation 1.03 |
| Placebo | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 1 hour post-dose | 4.30 Liters | Standard Deviation 1.06 |
| Placebo | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 23.75 hours post-dose | 4.30 Liters | Standard Deviation 0.99 |
| Placebo | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 0 minutes post-dose | 4.27 Liters | Standard Deviation 1.02 |
| Placebo | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 12 hours post-dose | 4.24 Liters | Standard Deviation 1.02 |
| Placebo | Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 | 4 hours post-dose | 4.30 Liters | Standard Deviation 0.98 |
Secondary
Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8
Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. FVC is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.
Time frame: Day 7, Day 8
Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 75 µg Indacaterol (LB) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 1 hour post-dose | 4.37 Liters | Standard Deviation 1.06 |
| 75 µg Indacaterol (LB) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 2 hours post-dose | 4.39 Liters | Standard Deviation 1.04 |
| 75 µg Indacaterol (LB) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 4 hours post-dose | 4.38 Liters | Standard Deviation 1.05 |
| 75 µg Indacaterol (LB) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 3 hours post-dose | 4.37 Liters | Standard Deviation 1.01 |
| 75 µg Indacaterol (LB) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 12 hours post-dose | 4.17 Liters | Standard Deviation 0.98 |
| 75 µg Indacaterol (LB) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 0 minutes post-dose | 4.28 Liters | Standard Deviation 1.07 |
| 75 µg Indacaterol (LB) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 23.75 hours post-dose | 4.41 Liters | Standard Deviation 1.08 |
| 75 µg Indacaterol (LB) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 23.16 hours post-dose | 4.32 Liters | Standard Deviation 1.08 |
| 75 µg Indacaterol (LB) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 15 minutes post-dose | 4.34 Liters | Standard Deviation 1.09 |
| 75 µg Indacaterol (LB) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 30 minutes post-dose | 4.36 Liters | Standard Deviation 1.08 |
| 75 µg Indacaterol (LB) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 8 hours post-dose | 4.24 Liters | Standard Deviation 0.97 |
| 75 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 23.16 hours post-dose | 4.30 Liters | Standard Deviation 0.97 |
| 75 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 1 hour post-dose | 4.35 Liters | Standard Deviation 0.97 |
| 75 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 8 hours post-dose | 4.29 Liters | Standard Deviation 0.94 |
| 75 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 4 hours post-dose | 4.39 Liters | Standard Deviation 0.91 |
| 75 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 0 minutes post-dose | 4.30 Liters | Standard Deviation 0.93 |
| 75 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 30 minutes post-dose | 4.36 Liters | Standard Deviation 0.96 |
| 75 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 3 hours post-dose | 4.40 Liters | Standard Deviation 0.93 |
| 75 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 23.75 hours post-dose | 4.34 Liters | Standard Deviation 0.97 |
| 75 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 15 minutes post-dose | 4.33 Liters | Standard Deviation 0.95 |
| 75 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 12 hours post-dose | 4.23 Liters | Standard Deviation 0.94 |
| 75 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 2 hours post-dose | 4.40 Liters | Standard Deviation 0.9 |
| 37.5 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 12 hours post-dose | 4.25 Liters | Standard Deviation 1.04 |
| 37.5 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 0 minutes post-dose | 4.35 Liters | Standard Deviation 1.06 |
| 37.5 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 2 hours post-dose | 4.42 Liters | Standard Deviation 1.02 |
| 37.5 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 3 hours post-dose | 4.46 Liters | Standard Deviation 1.03 |
| 37.5 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 15 minutes post-dose | 4.36 Liters | Standard Deviation 1.06 |
| 37.5 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 30 minutes post-dose | 4.37 Liters | Standard Deviation 1.06 |
| 37.5 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 1 hour post-dose | 4.41 Liters | Standard Deviation 1.05 |
| 37.5 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 4 hours post-dose | 4.44 Liters | Standard Deviation 0.99 |
| 37.5 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 8 hours post-dose | 4.31 Liters | Standard Deviation 1.05 |
| 37.5 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 23.16 hours post-dose | 4.29 Liters | Standard Deviation 1.08 |
| 37.5 µg Indacaterol (PoS) | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 23.75 hours post-dose | 4.34 Liters | Standard Deviation 1.08 |
| Placebo | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 4 hours post-dose | 4.32 Liters | Standard Deviation 1.03 |
| Placebo | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 30 minutes post-dose | 4.21 Liters | Standard Deviation 1.04 |
| Placebo | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 15 minutes post-dose | 4.21 Liters | Standard Deviation 1.04 |
| Placebo | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 8 hours post-dose | 4.31 Liters | Standard Deviation 1.01 |
| Placebo | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 12 hours post-dose | 4.21 Liters | Standard Deviation 1.03 |
| Placebo | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 0 minutes post-dose | 4.22 Liters | Standard Deviation 1 |
| Placebo | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 23.16 hours post-dose | 4.28 Liters | Standard Deviation 1.02 |
| Placebo | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 3 hours post-dose | 4.34 Liters | Standard Deviation 1.05 |
| Placebo | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 2 hours post-dose | 4.37 Liters | Standard Deviation 1.06 |
| Placebo | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 1 hour post-dose | 4.28 Liters | Standard Deviation 1.03 |
| Placebo | Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 | 23.75 hours post-dose | 4.36 Liters | Standard Deviation 1.02 |
Secondary
Number of Participants With Adverse Events as a Measure of Safety
Adverse event are defined as any unfavorable and unintended diagnosis, symptoms, sign (including an abnormal lab finding), syndrome or disease which either occurs during the study, having been absent at baseline, or if present at baseline appear to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization , cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards. Additional information about adverse events can be found in the Adverse Event section
Time frame: Up to 101 days
Population: Safety population inlcuded all participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 75 µg Indacaterol (LB) | Number of Participants With Adverse Events as a Measure of Safety | 14 Participants |
| 75 µg Indacaterol (PoS) | Number of Participants With Adverse Events as a Measure of Safety | 16 Participants |
| 37.5 µg Indacaterol (PoS) | Number of Participants With Adverse Events as a Measure of Safety | 17 Participants |
| Placebo | Number of Participants With Adverse Events as a Measure of Safety | 10 Participants |
Secondary
Number of Puffs of Rescue Medicine
Salbutamol (100 µg/puff) was used as rescued medicine. The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient and was recorded in the patient diary from Baseline until Day 8 of Treatment Period 4. Analysis of covariance with treatment, period, sequence, and subject nested within sequence as fixed effect.
Time frame: Up to 101 days
Population: Participants in the Pharmacodynamics Analysis set (included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement) who used rescue medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 75 µg Indacaterol (LB) | Number of Puffs of Rescue Medicine | 1.98 Puffs/day |
| 75 µg Indacaterol (PoS) | Number of Puffs of Rescue Medicine | 1.90 Puffs/day |
| 37.5 µg Indacaterol (PoS) | Number of Puffs of Rescue Medicine | 1.91 Puffs/day |
| Placebo | Number of Puffs of Rescue Medicine | 1.94 Puffs/day |
Secondary
Observed Maximum Concentration (Cmax) After Drug Administration
Time frame: Day 1, Day 7
Population: PK Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 75 µg Indacaterol (LB) | Observed Maximum Concentration (Cmax) After Drug Administration | Day 1 (n=31,30,31) | 72.9 pg/mL | Standard Deviation 25.7 |
| 75 µg Indacaterol (LB) | Observed Maximum Concentration (Cmax) After Drug Administration | Day 7 (n=33,31,31) | 112 pg/mL | Standard Deviation 27.1 |
| 75 µg Indacaterol (PoS) | Observed Maximum Concentration (Cmax) After Drug Administration | Day 1 (n=31,30,31) | 124 pg/mL | Standard Deviation 55.7 |
| 75 µg Indacaterol (PoS) | Observed Maximum Concentration (Cmax) After Drug Administration | Day 7 (n=33,31,31) | 174 pg/mL | Standard Deviation 61.4 |
| 37.5 µg Indacaterol (PoS) | Observed Maximum Concentration (Cmax) After Drug Administration | Day 1 (n=31,30,31) | 64.2 pg/mL | Standard Deviation 27.9 |
| 37.5 µg Indacaterol (PoS) | Observed Maximum Concentration (Cmax) After Drug Administration | Day 7 (n=33,31,31) | 90.5 pg/mL | Standard Deviation 23.9 |
Secondary
Peak Expiratory Flow Rate in the Morning in the Evening
PEFR was measured on all days from Screening Visit 2 to end of study visit: twice daily pre-dose (prior to Inhaled Corticosteroids) and approximately 12 hours post-dose (during the treatment period). Each subject was provided with a PEFR meter and recorded the PEFR readings in a daily diary. repeated measures. Analysis of covariance with treatment, period, sequence, day and treatment-day interaction as fixed effect and subject as a random effect and baseline PEFR as a covariate in the model.
Time frame: Up to 101 days
Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 75 µg Indacaterol (LB) | Peak Expiratory Flow Rate in the Morning in the Evening | Morning | 451.33 Liters per second | Standard Error 2.35 |
| 75 µg Indacaterol (LB) | Peak Expiratory Flow Rate in the Morning in the Evening | Evening | 474.09 Liters per second | Standard Error 2.18 |
| 75 µg Indacaterol (PoS) | Peak Expiratory Flow Rate in the Morning in the Evening | Evening | 464.39 Liters per second | Standard Error 2.33 |
| 75 µg Indacaterol (PoS) | Peak Expiratory Flow Rate in the Morning in the Evening | Morning | 447.15 Liters per second | Standard Error 2.5 |
| 37.5 µg Indacaterol (PoS) | Peak Expiratory Flow Rate in the Morning in the Evening | Morning | 444.11 Liters per second | Standard Error 2.47 |
| 37.5 µg Indacaterol (PoS) | Peak Expiratory Flow Rate in the Morning in the Evening | Evening | 463.28 Liters per second | Standard Error 2.3 |
| Placebo | Peak Expiratory Flow Rate in the Morning in the Evening | Morning | 421.58 Liters per second | Standard Error 2.41 |
| Placebo | Peak Expiratory Flow Rate in the Morning in the Evening | Evening | 433.60 Liters per second | Standard Error 2.24 |
Secondary
Peak FEV1 at Day 1 and Day 7
Spirometry was performed according to internationally accepted standards at 0, 15 and 30 minutes; 1,2,3,4,8,12 hours on Day 1 and 23.16 and 23.75 hours on Day 2 after 1 day of treatment and on Day 7 and Day 8 following 7 days of treatment. Peak FEV1 was the maximum FEV1 post treatment. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline included as a covariate.
Time frame: Day 1, Day 7
Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| 75 µg Indacaterol (LB) | Peak FEV1 at Day 1 and Day 7 | Day 7 (n=33,30,32,33) | 3.09 Liters |
| 75 µg Indacaterol (LB) | Peak FEV1 at Day 1 and Day 7 | Day 1 | 3.08 Liters |
| 75 µg Indacaterol (PoS) | Peak FEV1 at Day 1 and Day 7 | Day 1 | 3.11 Liters |
| 75 µg Indacaterol (PoS) | Peak FEV1 at Day 1 and Day 7 | Day 7 (n=33,30,32,33) | 3.11 Liters |
| 37.5 µg Indacaterol (PoS) | Peak FEV1 at Day 1 and Day 7 | Day 1 | 3.05 Liters |
| 37.5 µg Indacaterol (PoS) | Peak FEV1 at Day 1 and Day 7 | Day 7 (n=33,30,32,33) | 3.10 Liters |
| Placebo | Peak FEV1 at Day 1 and Day 7 | Day 7 (n=33,30,32,33) | 2.89 Liters |
| Placebo | Peak FEV1 at Day 1 and Day 7 | Day 1 | 2.85 Liters |
Secondary
Standardized FEV1 AUC Between Baseline (Pre-dose) and 12 Hour Post-dose (AUC0-12h)
Spirometry was conducted according to internationally accepted standards at predose, 5 , 15 and 30 min, 1, 2, 4, 8 and 12 hours post-dose on Day 1 and Day 7. The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 12 h post. Analysis of covariance with treatment, period, sequence and subject nested within sequence as fixed effects and FEV1 period baseline as a covariate.
Time frame: Day 1, Day 7
Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| 75 µg Indacaterol (LB) | Standardized FEV1 AUC Between Baseline (Pre-dose) and 12 Hour Post-dose (AUC0-12h) | Day 7 (n=31,29,30,31) | 2.93 Liters |
| 75 µg Indacaterol (LB) | Standardized FEV1 AUC Between Baseline (Pre-dose) and 12 Hour Post-dose (AUC0-12h) | Day 1 | 2.90 Liters |
| 75 µg Indacaterol (PoS) | Standardized FEV1 AUC Between Baseline (Pre-dose) and 12 Hour Post-dose (AUC0-12h) | Day 1 | 2.94 Liters |
| 75 µg Indacaterol (PoS) | Standardized FEV1 AUC Between Baseline (Pre-dose) and 12 Hour Post-dose (AUC0-12h) | Day 7 (n=31,29,30,31) | 2.92 Liters |
| 37.5 µg Indacaterol (PoS) | Standardized FEV1 AUC Between Baseline (Pre-dose) and 12 Hour Post-dose (AUC0-12h) | Day 1 | 2.87 Liters |
| 37.5 µg Indacaterol (PoS) | Standardized FEV1 AUC Between Baseline (Pre-dose) and 12 Hour Post-dose (AUC0-12h) | Day 7 (n=31,29,30,31) | 2.91 Liters |
| Placebo | Standardized FEV1 AUC Between Baseline (Pre-dose) and 12 Hour Post-dose (AUC0-12h) | Day 1 | 2.68 Liters |
| Placebo | Standardized FEV1 AUC Between Baseline (Pre-dose) and 12 Hour Post-dose (AUC0-12h) | Day 7 (n=31,29,30,31) | 2.70 Liters |
Secondary
Standardized FEV1 AUC Between Baseline (Pre-dose) and 4 Hour Post-dose (AUC0-4h)
Spirometry was conducted according to internationally accepted standards at predose, 5, 15 and 30 minutes, 1, 2 and 4 hours post-dose on Day 1 and Day 7. The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 4 h post. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.
Time frame: Day 1, Day 7
Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| 75 µg Indacaterol (LB) | Standardized FEV1 AUC Between Baseline (Pre-dose) and 4 Hour Post-dose (AUC0-4h) | Day 7 (n=33,30,32,33) | 2.96 Liters |
| 75 µg Indacaterol (LB) | Standardized FEV1 AUC Between Baseline (Pre-dose) and 4 Hour Post-dose (AUC0-4h) | Day 1 | 2.94 Liters |
| 75 µg Indacaterol (PoS) | Standardized FEV1 AUC Between Baseline (Pre-dose) and 4 Hour Post-dose (AUC0-4h) | Day 1 | 3.00 Liters |
| 75 µg Indacaterol (PoS) | Standardized FEV1 AUC Between Baseline (Pre-dose) and 4 Hour Post-dose (AUC0-4h) | Day 7 (n=33,30,32,33) | 2.98 Liters |
| 37.5 µg Indacaterol (PoS) | Standardized FEV1 AUC Between Baseline (Pre-dose) and 4 Hour Post-dose (AUC0-4h) | Day 1 | 2.94 Liters |
| 37.5 µg Indacaterol (PoS) | Standardized FEV1 AUC Between Baseline (Pre-dose) and 4 Hour Post-dose (AUC0-4h) | Day 7 (n=33,30,32,33) | 2.97 Liters |
| Placebo | Standardized FEV1 AUC Between Baseline (Pre-dose) and 4 Hour Post-dose (AUC0-4h) | Day 1 | 2.72 Liters |
| Placebo | Standardized FEV1 AUC Between Baseline (Pre-dose) and 4 Hour Post-dose (AUC0-4h) | Day 7 (n=33,30,32,33) | 2.73 Liters |
Secondary
Time to Peak FEV1 at Day 1 and Day 7
Spirometry was performed according to internationally accepted standards. Time to the peak (maximum) FEV1 is recorded. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.
Time frame: Day 1, Day 7
Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 75 µg Indacaterol (LB) | Time to Peak FEV1 at Day 1 and Day 7 | Day 7 (n=33,30,32,33) | 3.00 Hours |
| 75 µg Indacaterol (LB) | Time to Peak FEV1 at Day 1 and Day 7 | Day 1 | 3.98 Hours |
| 75 µg Indacaterol (PoS) | Time to Peak FEV1 at Day 1 and Day 7 | Day 7 (n=33,30,32,33) | 3.05 Hours |
| 75 µg Indacaterol (PoS) | Time to Peak FEV1 at Day 1 and Day 7 | Day 1 | 3.02 Hours |
| 37.5 µg Indacaterol (PoS) | Time to Peak FEV1 at Day 1 and Day 7 | Day 7 (n=33,30,32,33) | 3.00 Hours |
| 37.5 µg Indacaterol (PoS) | Time to Peak FEV1 at Day 1 and Day 7 | Day 1 | 3.00 Hours |
| Placebo | Time to Peak FEV1 at Day 1 and Day 7 | Day 7 (n=33,30,32,33) | 3.97 Hours |
| Placebo | Time to Peak FEV1 at Day 1 and Day 7 | Day 1 | 3.00 Hours |
Secondary
Time to Reach Maximum Concentration (Tmax) After Drug Administration
Time frame: Day1, Day 7
Population: PK Analysis Set
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 75 µg Indacaterol (LB) | Time to Reach Maximum Concentration (Tmax) After Drug Administration | Day 1 (n=31,30,31) | 0.27 Hours |
| 75 µg Indacaterol (LB) | Time to Reach Maximum Concentration (Tmax) After Drug Administration | Day 7 (n=33,31,31) | 0.25 Hours |
| 75 µg Indacaterol (PoS) | Time to Reach Maximum Concentration (Tmax) After Drug Administration | Day 1 (n=31,30,31) | 0.48 Hours |
| 75 µg Indacaterol (PoS) | Time to Reach Maximum Concentration (Tmax) After Drug Administration | Day 7 (n=33,31,31) | 0.48 Hours |
| 37.5 µg Indacaterol (PoS) | Time to Reach Maximum Concentration (Tmax) After Drug Administration | Day 1 (n=31,30,31) | 0.48 Hours |
| 37.5 µg Indacaterol (PoS) | Time to Reach Maximum Concentration (Tmax) After Drug Administration | Day 7 (n=33,31,31) | 0.25 Hours |
Secondary
Trough Forced Expiratory Volume in One Second (FEV1) After 1 Day of Treatment
Spirometry was performed according to internationally accepted standards at Day 2. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose at Day 2. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.
Time frame: Day 2
Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 75 µg Indacaterol (LB) | Trough Forced Expiratory Volume in One Second (FEV1) After 1 Day of Treatment | 2.83 Liters | Standard Error 0.03 |
| 75 µg Indacaterol (PoS) | Trough Forced Expiratory Volume in One Second (FEV1) After 1 Day of Treatment | 2.84 Liters | Standard Error 0.03 |
| 37.5 µg Indacaterol (PoS) | Trough Forced Expiratory Volume in One Second (FEV1) After 1 Day of Treatment | 2.81 Liters | Standard Error 0.03 |
| Placebo | Trough Forced Expiratory Volume in One Second (FEV1) After 1 Day of Treatment | 2.62 Liters | Standard Error 0.03 |