Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma

A Multicenter, Randomized, Double-blind, Placebo-controlled, 12-week Treatment, Parallel-group Study to Assess the Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate (75 and 150 µg o.d.) in Patients With Persistent Asthma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01609478

Enrollment

335

Registered

2012-06-01

Start date

2012-08-31

Completion date

2013-07-31

Last updated

2015-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

asthma

Brief summary

To provide the efficacy, safety and pharmacokinetics of indacaterol acetate in patients with persistent asthma to support dose selection of indacaterol in fixed dose combination QMF149.

Interventions

DRUGindacaterol

indacaterol acetate 75 µg or indacaterol acetate 150 µg delivered via Concept 1 inhaler

DRUGplacebo

placebo delivered via Concept 1 inhaler

DRUGmometasone furoate

via Twisthaler inhaler

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally meet the following criteria: * Patients who are receiving ICS treatment in a stable regimen for ≥ 4 weeks * Patients with a pre-bronchodilator FEV1 value of ≥ 40% and ≤ 80% of predicted normal value * Patients who demonstrate an increase of \>= 12% and 200 mL in FEV1 * ACQ-5 score ≥ 1.5

Exclusion criteria

* Patients who are current smokers or have a smoking history of greater than 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked). * Patients with chronic lung disease, including COPD, pulmonary tuberculosis, bronchiectasis, sarcoidosis, interstitial lung disease and cystic fibrosis. * Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study. Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame	Description
Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85)	after 12 weeks (Day 85)	Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 12 weeks (Day 85)

Secondary

Measure	Time frame	Description
Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.	Day 15, Day 29 and Day 57	Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 2 weeks (Day 15), 4 weeks (Day 29), and 8 weeks (Day 57) of treatment.
Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. FVC is measured on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at all time points
Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards.
Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Forced Expiratory Flow (FEF 25-75%) was measured via spirometry conducted according to internationally accepted standards.
Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 1, 2 Weeks, 12 Weeks	Forced Expiratory Volume in 1 second (FEV1)/Area Under the Curve(AUC) was measured via spirometry conducted according to internationally accepted standards.FEV1 AUC(5 min - 4 h), (5 min - 1 h) and (1 h - 4 h) are measured at Day 1, 2 Weeks (Day 14) and 12 Weeks (Day84) and defined as average of FEV1 at specified timepoints above.
Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)	Day 1, 2 weeks (Day 14), 12 weeks (Day 84)	Peak Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Peak FEV1 is defined as the maximum FEV1 during the first 4 h post morning dosing at Day 1, 2Weeks and 12 Weeks.
Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment	after 4 weeks (Day 29) and after 8 weeks (Day 57)	The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).
Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.	baseline, 4weeks, 8 weeks and 12 weeks	PEFR is measured with portable spirometer by participants every morning and evening at home.
The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment	12 weeks	Participants record the number of puffs of rescue medication taken in the previous 12 hours in the morning and nighttime.
Asthma Control Questionnaire 5 (ACQ-5) After 12 Weeks (Day 85)	aftert 12 weeks (Day 85)	The Asthma Control Questionnaire (ACQ-5) is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.
Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	12 weeks	Duration of treatment until first asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is systemic corticosteroids (SCS) use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	12 weeks	Annual incidence rate of asthma exacerbation by severity of exacerbation. The number of asthma exacerbation is used to calculate annual incidence rate. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations. Number of the asthma exacerbation will be analyzed by the negative binomial regression including treatment, history of asthma exacerbation in the 12 months prior to screening and region as factors and FEV1 prior to inhalation and FEV1 30 min post inhalation of salbutamol/albuterol (components of SABA reversibility) as covariates. The estimates are obtained from the model and so we cannot specify a formula.
Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	12 weeks	Duration of asthma exacerbations by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	12 weeks	The percentage of patients with at least one asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
Time to Permanent Study Discontinuation Due to Asthma Exacerbation Over the 12 Week Treatment Period	12 weeks	Time to permanent study discontinuation due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
The Percentage of Patients Who Permanently Discontinued Study Due to Asthma Exacerbation Over the 12 Week Treatment Period	12 weeks	The percentage of patients who permanently discontinued study due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	12 weeks	Total amounts (in doses) of systemic corticosteroids (SCS) used to treat asthma exacerbations.SCS includes Intramuscular (IM), Intravenous (IV) and Oral. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
Plasma Indacaterol Concentrations at Day 1 and Day 14	Day 1 and Day 14	Maximum plasma concentration after drug administration (Cmax) was measured for indacaterol acetate 75 µg and indacaterol acetate 150 µg for Pharmacokinetic (PK) Subgroup
Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment	4 Weeks, 12 Weeks	The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and \> 1.5 as marked clinically important differences for any individual domain or for the overall summary score.

Countries

Bulgaria, Canada, Germany, Japan, Netherlands, Poland, Slovakia, South Korea

Participant flow

Participants by arm

Arm	Count
Indacaterol Acetate 75 µg indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od	111
Indacaterol Acetate 150 µg indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od	108
Placebo placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od	116
Total	335

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	3	1	5
Overall Study	Non-Compliance with study treatment	1	0	0
Overall Study	Physician Decision	1	0	1
Overall Study	Protocol Deviation	0	1	1
Overall Study	Withdrawal by Subject	2	0	2

Baseline characteristics

Characteristic	Indacaterol Acetate 75 µg	Indacaterol Acetate 150 µg	Placebo	Total
Age, Continuous	50.7 years STANDARD_DEVIATION 14.74	48.1 years STANDARD_DEVIATION 13.53	49.8 years STANDARD_DEVIATION 12.96	49.6 years STANDARD_DEVIATION 13.76
Sex: Female, Male Female	59 Participants	60 Participants	61 Participants	180 Participants
Sex: Female, Male Male	52 Participants	48 Participants	55 Participants	155 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	19 / 110	20 / 108	28 / 115
serious Total, serious adverse events	2 / 110	0 / 108	2 / 115

Outcome results

Primary

Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85)

Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 12 weeks (Day 85)

Time frame: after 12 weeks (Day 85)

Population: The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Indacaterol Acetate 75 µg	Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85)	2.190 Liters	Standard Error 0.0283
Indacaterol Acetate 150 µg	Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85)	2.216 Liters	Standard Error 0.0281
Placebo	Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85)	2.110 Liters	Standard Error 0.0275

Secondary

Asthma Control Questionnaire 5 (ACQ-5) After 12 Weeks (Day 85)

The Asthma Control Questionnaire (ACQ-5) is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.

Time frame: aftert 12 weeks (Day 85)

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Indacaterol Acetate 75 µg	Asthma Control Questionnaire 5 (ACQ-5) After 12 Weeks (Day 85)	1.31 Units on a Scale	Standard Error 0.094
Indacaterol Acetate 150 µg	Asthma Control Questionnaire 5 (ACQ-5) After 12 Weeks (Day 85)	1.42 Units on a Scale	Standard Error 0.093
Placebo	Asthma Control Questionnaire 5 (ACQ-5) After 12 Weeks (Day 85)	1.32 Units on a Scale	Standard Error 0.092

Secondary

Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment

The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).

Time frame: after 4 weeks (Day 29) and after 8 weeks (Day 57)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Indacaterol Acetate 75 µg	Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment	Day 29 (n=103, 104, 108)	1.43 units on a scale	Standard Error 0.088
Indacaterol Acetate 75 µg	Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment	Day 57 (n= 103, 104, 108)	1.42 units on a scale	Standard Error 0.093
Indacaterol Acetate 150 µg	Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment	Day 29 (n=103, 104, 108)	1.39 units on a scale	Standard Error 0.088
Indacaterol Acetate 150 µg	Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment	Day 57 (n= 103, 104, 108)	1.29 units on a scale	Standard Error 0.093
Placebo	Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment	Day 29 (n=103, 104, 108)	1.55 units on a scale	Standard Error 0.086
Placebo	Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment	Day 57 (n= 103, 104, 108)	1.46 units on a scale	Standard Error 0.091

Secondary

Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment

The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and \> 1.5 as marked clinically important differences for any individual domain or for the overall summary score.

Time frame: 4 Weeks, 12 Weeks

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Indacaterol Acetate 75 µg	Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment	Day 29 (n=103,104, 108)	5.52 Units on a Scale	Standard Error 0.082
Indacaterol Acetate 75 µg	Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment	Day 85 (n=103,104, 108)	5.64 Units on a Scale	Standard Error 0.088
Indacaterol Acetate 150 µg	Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment	Day 29 (n=103,104, 108)	5.48 Units on a Scale	Standard Error 0.082
Indacaterol Acetate 150 µg	Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment	Day 85 (n=103,104, 108)	5.47 Units on a Scale	Standard Error 0.087
Placebo	Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment	Day 29 (n=103,104, 108)	5.38 Units on a Scale	Standard Error 0.08
Placebo	Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment	Day 85 (n=103,104, 108)	5.60 Units on a Scale	Standard Error 0.086

Secondary

Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period

Duration of asthma exacerbations by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.

Time frame: 12 weeks

Arm	Measure	Group	Value (MEAN)	Dispersion
Indacaterol Acetate 75 µg	Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	moderate asthma exacerbations	0.6 days	Standard Deviation 3.26
Indacaterol Acetate 75 µg	Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	mild asthma exacerbations	0.3 days	Standard Deviation 2.11
Indacaterol Acetate 75 µg	Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	moderate or severe exacerbations	0.7 days	Standard Deviation 3.32
Indacaterol Acetate 75 µg	Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	any asthma exacerbations	1.0 days	Standard Deviation 3.88
Indacaterol Acetate 75 µg	Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Severe asthma exacerbations	0.1 days	Standard Deviation 0.67
Indacaterol Acetate 150 µg	Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	mild asthma exacerbations	0.4 days	Standard Deviation 2.47
Indacaterol Acetate 150 µg	Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	moderate or severe exacerbations	0.6 days	Standard Deviation 2.5
Indacaterol Acetate 150 µg	Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	any asthma exacerbations	0.9 days	Standard Deviation 3.62
Indacaterol Acetate 150 µg	Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	moderate asthma exacerbations	0.6 days	Standard Deviation 2.5
Indacaterol Acetate 150 µg	Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Severe asthma exacerbations	0.0 days	Standard Deviation 0
Placebo	Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Severe asthma exacerbations	0.1 days	Standard Deviation 1.59
Placebo	Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	moderate asthma exacerbations	0.6 days	Standard Deviation 3.53
Placebo	Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	moderate or severe exacerbations	0.8 days	Standard Deviation 4.11
Placebo	Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	mild asthma exacerbations	0.5 days	Standard Deviation 2.54
Placebo	Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	any asthma exacerbations	1.3 days	Standard Deviation 4.74

Secondary

Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85

Forced Expiratory Flow (FEF 25-75%) was measured via spirometry conducted according to internationally accepted standards.

Time frame: Day 1, Day 2, Day 14, Day 15, Day 84, Day 85

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 2 / 23 hr 10min post-dose (n=107,104,110)	1.407 liters/second	Standard Error 0.0322
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 5 min post-dose (n=107,105,111)	1.420 liters/second	Standard Error 0.0237
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 5 min post-dose (n=107,105,111)	1.505 liters/second	Standard Error 0.035
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 2 hr post-dose (n=106,104,111)	1.571 liters/second	Standard Error 0.0409
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 1 hr post-dose (n=107,104,111)	1.471 liters/second	Standard Error 0.0307
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 15 min post-dose (n=107,105,111)	1.540 liters/second	Standard Error 0.0366
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 6 hr post-dose (n=24,24,26)	1.364 liters/second	Standard Error 0.0889
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 4 hr post-dose (n=106,101,111)	1.548 liters/second	Standard Error 0.0398
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 30 min post-dose (n=107,104,111)	1.532 liters/second	Standard Error 0.0383
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 30 min post-dose (n=107,104,111)	1.548 liters/second	Standard Error 0.0412
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 15 min post-dose (n=107,105,111)	1.449 liters/second	Standard Error 0.0254
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 1 hr post-dose (n=107,104,111)	1.569 liters/second	Standard Error 0.04
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 15 min post-dose (n=107,105,111)	1.530 liters/second	Standard Error 0.0393
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 2 hr post-dose (n=106,104,111)	1.508 liters/second	Standard Error 0.0307
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 2 hr post-dose (n=106,104,111)	1.551 liters/second	Standard Error 0.038
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 85 / 23 hr 10min post-dose (n=107,104,110)	1.437 liters/second	Standard Error 0.0378
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 30 min post-dose (n=107,104,111)	1.467 liters/second	Standard Error 0.029
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 4 hr post-dose (n=107,101,111)	1.526 liters/second	Standard Error 0.0434
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 2 / 23 hr 45min post-dose (n=107,104,111)	1.436 liters/second	Standard Error 0.0399
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 85 / 23 hr 45min post-dose (n=107,104,111)	1.476 liters/second	Standard Error 0.0428
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 6 hr post-dose (n=24,24,26)	1.370 liters/second	Standard Error 0.0843
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 1hr post-dose (n=107,104,111)	1.578 liters/second	Standard Error 0.0408
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 4 hr post-dose (n=107,101,111)	1.479 liters/second	Standard Error 0.0327
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 15 / 23 hr 10min post-dose (n=107,104,110)	1.421 liters/second	Standard Error 0.0383
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 5 min post-dose (n=107,105,111)	1.535 liters/second	Standard Error 0.0391
Indacaterol Acetate 75 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 15 / 23 hr 45min post-dose (n=107,104,111)	1.430 liters/second	Standard Error 0.0431
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 4 hr post-dose (n=107,101,111)	1.625 liters/second	Standard Error 0.0331
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 15 / 23 hr 45min post-dose (n=107,104,111)	1.492 liters/second	Standard Error 0.0431
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 5 min post-dose (n=107,105,111)	1.485 liters/second	Standard Error 0.0235
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 5 min post-dose (n=107,105,111)	1.627 liters/second	Standard Error 0.0394
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 15 min post-dose (n=107,105,111)	1.675 liters/second	Standard Error 0.0396
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 6 hr post-dose (n=24,24,26)	1.620 liters/second	Standard Error 0.084
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 30 min post-dose (n=107,104,111)	10659 liters/second	Standard Error 0.0414
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 1hr post-dose (n=107,104,111)	1.687 liters/second	Standard Error 0.0415
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 2 / 23 hr 10min post-dose (n=107,104,110)	1.520 liters/second	Standard Error 0.0328
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 4 hr post-dose (n=106,101,111)	1.648 liters/second	Standard Error 0.0405
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 30 min post-dose (n=107,104,111)	1.568 liters/second	Standard Error 0.029
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 85 / 23 hr 10min post-dose (n=107,104,110)	1.507 liters/second	Standard Error 0.038
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 85 / 23 hr 45min post-dose (n=107,104,111)	1.496 liters/second	Standard Error 0.0427
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 2 hr post-dose (n=106,104,111)	1.704 liters/second	Standard Error 0.0411
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 2 / 23 hr 45min post-dose (n=107,104,111)	1.524 liters/second	Standard Error 0.0401
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 5 min post-dose (n=107,105,111)	1.571 liters/second	Standard Error 0.0354
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 15 min post-dose (n=107,105,111)	1.597 liters/second	Standard Error 0.037
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 1 hr post-dose (n=107,104,111)	1.594 liters/second	Standard Error 0.0309
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 30 min post-dose (n=107,104,111)	1.607 liters/second	Standard Error 0.0386
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 1 hr post-dose (n=107,104,111)	1.664 liters/second	Standard Error 0.0402
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 2 hr post-dose (n=106,104,111)	1.676 liters/second	Standard Error 0.0385
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 2 hr post-dose (n=106,104,111)	1.632 liters/second	Standard Error 0.031
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 4 hr post-dose (n=107,101,111)	1.628 liters/second	Standard Error 0.0445
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 15 min post-dose (n=107,105,111)	1.563 liters/second	Standard Error 0.0256
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 6 hr post-dose (n=24,24,26)	1.519 liters/second	Standard Error 0.0792
Indacaterol Acetate 150 µg	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 15 / 23 hr 10min post-dose (n=107,104,110)	1.442 liters/second	Standard Error 0.0386
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 85 / 23 hr 45min post-dose (n=107,104,111)	1.378 liters/second	Standard Error 0.0418
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 5 min post-dose (n=107,105,111)	1.295 liters/second	Standard Error 0.0226
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 15 min post-dose (n=107,105,111)	1.295 liters/second	Standard Error 0.0247
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 30 min post-dose (n=107,104,111)	1.310 liters/second	Standard Error 0.028
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 1 hr post-dose (n=107,104,111)	1.297 liters/second	Standard Error 0.0296
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 2 hr post-dose (n=106,104,111)	1.348 liters/second	Standard Error 0.0297
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 4 hr post-dose (n=107,101,111)	1.329 liters/second	Standard Error 0.0313
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 6 hr post-dose (n=24,24,26)	1.332 liters/second	Standard Error 0.0832
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 2 / 23 hr 10min post-dose (n=107,104,110)	1.310 liters/second	Standard Error 0.0315
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 2 / 23 hr 45min post-dose (n=107,104,111)	1.326 liters/second	Standard Error 0.0382
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 5 min post-dose (n=107,105,111)	1.318 liters/second	Standard Error 0.0348
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 15 min post-dose (n=107,105,111)	1.351 liters/second	Standard Error 0.0362
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 30 min post-dose (n=107,104,111)	1.336 liters/second	Standard Error 0.0376
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 1 hr post-dose (n=107,104,111)	1.343 liters/second	Standard Error 0.0391
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 2 hr post-dose (n=106,104,111)	1.338 liters/second	Standard Error 0.0379
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 4 hr post-dose (n=107,101,111)	1.339 liters/second	Standard Error 0.0426
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 6 hr post-dose (n=24,24,26)	1.363 liters/second	Standard Error 0.0808
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 15 / 23 hr 10min post-dose (n=107,104,110)	1.315 liters/second	Standard Error 0.0377
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 15 / 23 hr 45min post-dose (n=107,104,111)	1.319 liters/second	Standard Error 0.042
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 5 min post-dose (n=107,105,111)	1.363 liters/second	Standard Error 0.039
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 15 min post-dose (n=107,105,111)	1.372 liters/second	Standard Error 0.0392
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 30 min post-dose (n=107,104,111)	1.368 liters/second	Standard Error 0.0411
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 1hr post-dose (n=107,104,111)	1.404 liters/second	Standard Error 0.0404
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 2 hr post-dose (n=106,104,111)	1.382 liters/second	Standard Error 0.0409
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 4 hr post-dose (n=106,101,111)	1.350 liters/second	Standard Error 0.397
Placebo	Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 85 / 23 hr 10min post-dose (n=107,104,110)	1.328 liters/second	Standard Error 0.0373

Secondary

Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85

Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards.

Time frame: Day 1, Day 2, Day 14, Day 15, Day 84, Day 85

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 6 hr post-dose (n=24,24,26)	64.716 ratio	Standard Error 0.9815
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 15 min post-dose (n=107,105,111)	65.602 ratio	Standard Error 0.3854
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 30 min post-dose (n=107,104,111)	65.738 ratio	Standard Error 0.4626
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 1 hr post-dose (n=107,104,111)	66.089 ratio	Standard Error 0.4465
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 2 hr post-dose (n=106,104,111)	66.607 ratio	Standard Error 0.4705
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 4 hr post-dose (n=107,101,111)	66.094 ratio	Standard Error 0.5098
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 5 min post-dose (n=107,105,111)	65.608 ratio	Standard Error 0.3659
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 2 / 23 hr 10min post-dose (n=107,104,110)	65.465 ratio	Standard Error 0.5112
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 2 / 23 hr 45min post-dose (n=107,104,111)	65.809 ratio	Standard Error 0.5299
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 5 min post-dose (n=107,105,111)	66.548 ratio	Standard Error 0.5102
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 15 min post-dose (n=107,105,111)	67.187 ratio	Standard Error 0.5042
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 30 min post-dose (n=107,104,111)	67.024 ratio	Standard Error 0.5601
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 1 hr post-dose (n=107,104,111)	67.100 ratio	Standard Error 0.5446
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 2 hr post-dose (n=106,104,111)	67.538 ratio	Standard Error 0.5486
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 4 hr post-dose (n=107,101,111)	66.866 ratio	Standard Error 0.5763
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 6 hr post-dose (n=24,24,26)	64.792 ratio	Standard Error 1.0246
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 15 / 23 hr 10min post-dose (n=107,104,110)	65.436 ratio	Standard Error 0.5564
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 15 / 23 hr 45min post-dose (n=107,104,111)	65.606 ratio	Standard Error 0.5871
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 5 min post-dose (n=107,105,111)	67.040 ratio	Standard Error 0.5442
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 15 min post-dose (n=107,105,111)	67.162 ratio	Standard Error 0.5671
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 30 min post-dose (n=107,104,111)	66.936 ratio	Standard Error 0.6017
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 1hr post-dose (n=107,104,111)	3.394 ratio	Standard Error 0.0339
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 2 hr post-dose (n=106,104,111)	3.413 ratio	Standard Error 0.0334
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 4 hr post-dose (n=106,101,111)	3.346 ratio	Standard Error 0.035
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 85 / 23 hr 10min post-dose (n=107,104,110)	3.350 ratio	Standard Error 0.0342
Indacaterol Acetate 75 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 85 / 23 hr 45min post-dose (n=107,104,111)	3.343 ratio	Standard Error 0.0367
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 2 / 23 hr 45min post-dose (n=107,104,111)	66.791 ratio	Standard Error 0.5323
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 30 min post-dose (n=107,104,111)	67.865 ratio	Standard Error 0.6031
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 5 min post-dose (n=107,105,111)	67.366 ratio	Standard Error 0.5172
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 15 min post-dose (n=107,105,111)	67.577 ratio	Standard Error 0.5093
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 85 / 23 hr 10min post-dose (n=107,104,110)	3.300 ratio	Standard Error 0.0347
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 30 min post-dose (n=107,104,111)	67.765 ratio	Standard Error 0.5633
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 1hr post-dose (n=107,104,111)	3.393 ratio	Standard Error 0.0346
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 1 hr post-dose (n=107,104,111)	68.262 ratio	Standard Error 0.5476
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 2 hr post-dose (n=106,104,111)	68.397 ratio	Standard Error 0.554
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 4 hr post-dose (n=107,101,111)	68.044 ratio	Standard Error 0.5871
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 2 hr post-dose (n=106,104,111)	3.382 ratio	Standard Error 0.0335
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 6 hr post-dose (n=24,24,26)	67.346 ratio	Standard Error 0.9676
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 15 / 23 hr 10min post-dose (n=107,104,110)	65.930 ratio	Standard Error 0.5597
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 15 / 23 hr 45min post-dose (n=107,104,111)	66.435 ratio	Standard Error 0.5887
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 5 min post-dose (n=107,105,111)	66.049 ratio	Standard Error 0.3641
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 15 min post-dose (n=107,105,111)	67.039 ratio	Standard Error 0.3898
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 4 hr post-dose (n=106,101,111)	3.363 ratio	Standard Error 0.0356
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 30 min post-dose (n=107,104,111)	67.189 ratio	Standard Error 0.4607
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 5 min post-dose (n=107,105,111)	67.762 ratio	Standard Error 0.5498
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 1 hr post-dose (n=107,104,111)	67.620 ratio	Standard Error 0.4485
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 2 hr post-dose (n=106,104,111)	67.824 ratio	Standard Error 0.4727
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 4 hr post-dose (n=107,101,111)	67.968 ratio	Standard Error 0.5137
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 15 min post-dose (n=107,105,111)	67.907 ratio	Standard Error 0.5719
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 6 hr post-dose (n=24,24,26)	68.846 ratio	Standard Error 0.922
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 2 / 23 hr 10min post-dose (n=107,104,110)	66.942 ratio	Standard Error 0.5197
Indacaterol Acetate 150 µg	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 85 / 23 hr 45min post-dose (n=107,104,111)	3.321 ratio	Standard Error 0.0368
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 6 hr post-dose (n=24,24,26)	63.773 ratio	Standard Error 0.9135
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 2 hr post-dose (n=106,104,111)	64.141 ratio	Standard Error 0.4534
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 5 min post-dose (n=107,105,111)	63.461 ratio	Standard Error 0.3508
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 5 min post-dose (n=107,105,111)	64.362 ratio	Standard Error 0.5075
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 30 min post-dose (n=107,104,111)	64.848 ratio	Standard Error 0.5966
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 15 / 23 hr 45min post-dose (n=107,104,111)	63.726 ratio	Standard Error 0.5729
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 15 min post-dose (n=107,105,111)	64.702 ratio	Standard Error 0.4986
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 4 hr post-dose (n=106,101,111)	3.257 ratio	Standard Error 0.0349
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 15 min post-dose (n=107,105,111)	63.537 ratio	Standard Error 0.3759
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 30 min post-dose (n=107,104,111)	64.192 ratio	Standard Error 0.5476
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 15 min post-dose (n=107,105,111)	65.074 ratio	Standard Error 0.5646
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 4 hr post-dose (n=107,101,111)	64.212 ratio	Standard Error 0.4871
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 1 hr post-dose (n=107,104,111)	64.383 ratio	Standard Error 0.5327
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 1hr post-dose (n=107,104,111)	3.262 ratio	Standard Error 0.0336
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 30 min post-dose (n=107,104,111)	63.767 ratio	Standard Error 0.4454
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 2 hr post-dose (n=106,104,111)	64.617 ratio	Standard Error 0.5431
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 85 / 23 hr 10min post-dose (n=107,104,110)	3.287 ratio	Standard Error 0.0339
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 2 / 23 hr 45min post-dose (n=107,104,111)	63.741 ratio	Standard Error 0.5057
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 4 hr post-dose (n=107,101,111)	64.426 ratio	Standard Error 0.5632
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 2 / 23 hr 10min post-dose (n=107,104,110)	63.822 ratio	Standard Error 0.5006
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 1 / 1 hr post-dose (n=107,104,111)	63.744 ratio	Standard Error 0.4298
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 14 / 6 hr post-dose (n=24,24,26)	64.167 ratio	Standard Error 0.9834
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 2 hr post-dose (n=106,104,111)	3.292 ratio	Standard Error 0.0332
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 84 / 5 min post-dose (n=107,105,111)	64.850 ratio	Standard Error 0.5422
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 15 / 23 hr 10min post-dose (n=107,104,110)	64.027 ratio	Standard Error 0.5455
Placebo	Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85	Day 85 / 23 hr 45min post-dose (n=107,104,111)	3.294 ratio	Standard Error 0.036

Secondary

Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points

Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. FVC is measured on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at all time points

Time frame: Day 1, Day 2, Day 14, Day 15, Day 84, Day 85

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 1 / 6 hr post-dose (n=24,24,26)	3.299 liters	Standard Error 0.0545
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 1 / 15 min post-dose (n=107,105,111)	3.372 liters	Standard Error 0.024
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 1 / 30 min post-dose (n=107,104,111)	3.378 liters	Standard Error 0.0236
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 1 / 1 hr post-dose (n=107,104,111)	3.356 liters	Standard Error 0.0237
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 1 / 2 hr post-dose (n=106,104,111)	3.366 liters	Standard Error 0.0256
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 1 / 4 hr post-dose (n=107,101,111)	3.346 liters	Standard Error 0.0304
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 1 / 5 min post-dose (n=107,105,111)	3.342 liters	Standard Error 0.0198
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 2 / 23 hr 10min post-dose (n=107,104,110)	3.314 liters	Standard Error 0.0282
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 2 / 23 hr 45min post-dose (n=107,104,111)	3.313 liters	Standard Error 0.0309
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 14 / 5 min post-dose (n=107,105,111)	3.404 liters	Standard Error 0.0327
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 14 / 15 min post-dose (n=107,105,111)	3.397 liters	Standard Error 0.034
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 14 / 30 min post-dose (n=107,104,111)	3.412 liters	Standard Error 0.0341
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 14 / 1 hr post-dose (n=107,104,111)	3.408 liters	Standard Error 0.0324
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 14 / 2 hr post-dose (n=106,104,111)	3.402 liters	Standard Error 0.0325
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 14 / 4 hr post-dose (n=107,101,111)	3.368 liters	Standard Error 0.0329
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 14 / 6 hr post-dose (n=24,24,26)	3.332 liters	Standard Error 0.062
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 15 / 23 hr 10min post-dose (n=107,104,110)	3.324 liters	Standard Error 0.0298
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 15 / 23 hr 45min post-dose (n=107,104,111)	3.347 liters	Standard Error 0.0307
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 84 / 5 min post-dose (n=107,105,111)	3.381 liters	Standard Error 0.0331
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 84 / 15 min post-dose (n=107,105,111)	3.393 liters	Standard Error 0.0353
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 84 / 30 min post-dose (n=107,104,111)	3.424 liters	Standard Error 0.035
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 84 / 1hr post-dose (n=107,104,111)	3.394 liters	Standard Error 0.0339
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 84 / 2 hr post-dose (n=106,104,111)	3.413 liters	Standard Error 0.0334
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 84 / 4 hr post-dose (n=106,101,111)	3.346 liters	Standard Error 0.035
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 85 / 23 hr 10min post-dose (n=107,104,110)	3.350 liters	Standard Error 0.0342
Indacaterol Acetate 75 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 85 / 23 hr 45min post-dose (n=107,104,111)	3.343 liters	Standard Error 0.0367
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 2 / 23 hr 45min post-dose (n=107,104,111)	3.341 liters	Standard Error 0.0314
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 84 / 30 min post-dose (n=107,104,111)	3.399 liters	Standard Error 0.0352
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 14 / 5 min post-dose (n=107,105,111)	3.364 liters	Standard Error 0.0332
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 14 / 15 min post-dose (n=107,105,111)	3.377 liters	Standard Error 0.0343
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 85 / 23 hr 10min post-dose (n=107,104,110)	3.300 liters	Standard Error 0.0347
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 14 / 30 min post-dose (n=107,104,111)	3.389 liters	Standard Error 0.0345
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 84 / 1hr post-dose (n=107,104,111)	3.393 liters	Standard Error 0.0346
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 14 / 1 hr post-dose (n=107,104,111)	3.379 liters	Standard Error 0.0327
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 14 / 2 hr post-dose (n=106,104,111)	3.395 liters	Standard Error 0.0329
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 14 / 4 hr post-dose (n=107,101,111)	3.338 liters	Standard Error 0.0336
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 84 / 2 hr post-dose (n=106,104,111)	3.382 liters	Standard Error 0.0335
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 14 / 6 hr post-dose (n=24,24,26)	3.426 liters	Standard Error 0.0584
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 15 / 23 hr 10min post-dose (n=107,104,110)	3.311 liters	Standard Error 0.0302
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 15 / 23 hr 45min post-dose (n=107,104,111)	3.313 liters	Standard Error 0.0311
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 1 / 5 min post-dose (n=107,105,111)	3.338 liters	Standard Error 0.0198
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 1 / 15 min post-dose (n=107,105,111)	3.348 liters	Standard Error 0.0241
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 84 / 4 hr post-dose (n=106,101,111)	3.363 liters	Standard Error 0.0356
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 1 / 30 min post-dose (n=107,104,111)	3.367 liters	Standard Error 0.0236
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 84 / 5 min post-dose (n=107,105,111)	3.374 liters	Standard Error 0.0335
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 1 / 1 hr post-dose (n=107,104,111)	3.333 liters	Standard Error 0.0239
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 1 / 2 hr post-dose (n=106,104,111)	3.367 liters	Standard Error 0.0258
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 1 / 4 hr post-dose (n=107,101,111)	3.342 liters	Standard Error 0.0307
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 84 / 15 min post-dose (n=107,105,111)	3.392 liters	Standard Error 0.0355
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 1 / 6 hr post-dose (n=24,24,26)	3.345 liters	Standard Error 0.0507
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 2 / 23 hr 10min post-dose (n=107,104,110)	3.303 liters	Standard Error 0.029
Indacaterol Acetate 150 µg	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 85 / 23 hr 45min post-dose (n=107,104,111)	3.321 liters	Standard Error 0.0368
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 1 / 6 hr post-dose (n=24,24,26)	3.280 liters	Standard Error 0.0509
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 1 / 2 hr post-dose (n=106,104,111)	3.268 liters	Standard Error 0.0247
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 1 / 5 min post-dose (n=107,105,111)	3.235 liters	Standard Error 0.019
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 14 / 5 min post-dose (n=107,105,111)	3.212 liters	Standard Error 0.0326
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 84 / 30 min post-dose (n=107,104,111)	3.282 liters	Standard Error 0.0349
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 15 / 23 hr 45min post-dose (n=107,104,111)	3.260 liters	Standard Error 0.0301
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 14 / 15 min post-dose (n=107,105,111)	3.213 liters	Standard Error 0.0336
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 84 / 4 hr post-dose (n=106,101,111)	3.257 liters	Standard Error 0.0349
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 1 / 15 min post-dose (n=107,105,111)	3.238 liters	Standard Error 0.0232
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 14 / 30 min post-dose (n=107,104,111)	3.246 liters	Standard Error 0.0336
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 84 / 15 min post-dose (n=107,105,111)	3.275 liters	Standard Error 0.0351
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 1 / 4 hr post-dose (n=107,101,111)	3.238 liters	Standard Error 0.029
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 14 / 1 hr post-dose (n=107,104,111)	3.206 liters	Standard Error 0.0319
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 84 / 1hr post-dose (n=107,104,111)	3.262 liters	Standard Error 0.0336
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 1 / 30 min post-dose (n=107,104,111)	3.239 liters	Standard Error 0.0227
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 14 / 2 hr post-dose (n=106,104,111)	3.207 liters	Standard Error 0.0323
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 85 / 23 hr 10min post-dose (n=107,104,110)	3.287 liters	Standard Error 0.0339
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 2 / 23 hr 45min post-dose (n=107,104,111)	3.269 liters	Standard Error 0.0297
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 14 / 4 hr post-dose (n=107,101,111)	3.217 liters	Standard Error 0.0323
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 2 / 23 hr 10min post-dose (n=107,104,110)	3.254 liters	Standard Error 0.0279
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 1 / 1 hr post-dose (n=107,104,111)	3.241 liters	Standard Error 0.0229
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 14 / 6 hr post-dose (n=24,24,26)	3.257 liters	Standard Error 0.0602
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 84 / 2 hr post-dose (n=106,104,111)	3.292 liters	Standard Error 0.0332
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 84 / 5 min post-dose (n=107,105,111)	3.263 liters	Standard Error 0.0331
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 15 / 23 hr 10min post-dose (n=107,104,110)	3.237 liters	Standard Error 0.0294
Placebo	Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points	Day 85 / 23 hr 45min post-dose (n=107,104,111)	3.294 liters	Standard Error 0.036

Secondary

Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.

PEFR is measured with portable spirometer by participants every morning and evening at home.

Time frame: baseline, 4weeks, 8 weeks and 12 weeks

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Indacaterol Acetate 75 µg	Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.	Morning Baseline - <4 weeks (n=104,100,109)	326.98 liters/second	Standard Error 3.741
Indacaterol Acetate 75 µg	Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.	Evening baseline - <4 weeks (n=104,100,109)	332.96 liters/second	Standard Error 3.477
Indacaterol Acetate 75 µg	Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.	Morning 4 weeks - <8 weeks (n=104,100,109)	328.45 liters/second	Standard Error 4.374
Indacaterol Acetate 75 µg	Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.	Evening 4 weeks - <8 weeks (n=104,100,109)	333.36 liters/second	Standard Error 4.221
Indacaterol Acetate 75 µg	Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.	Morning 8 weeks - <12 weeks (n=104,100,109)	329.85 liters/second	Standard Error 4.699
Indacaterol Acetate 75 µg	Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.	Evening 8 weeks - <12 weeks (n=104,100,109)	332.61 liters/second	Standard Error 4.628
Indacaterol Acetate 150 µg	Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.	Evening 8 weeks - <12 weeks (n=104,100,109)	342.40 liters/second	Standard Error 4.718
Indacaterol Acetate 150 µg	Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.	Morning Baseline - <4 weeks (n=104,100,109)	335.44 liters/second	Standard Error 3.842
Indacaterol Acetate 150 µg	Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.	Evening 4 weeks - <8 weeks (n=104,100,109)	344.63 liters/second	Standard Error 4.323
Indacaterol Acetate 150 µg	Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.	Morning 8 weeks - <12 weeks (n=104,100,109)	334.83 liters/second	Standard Error 4.783
Indacaterol Acetate 150 µg	Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.	Evening baseline - <4 weeks (n=104,100,109)	345.99 liters/second	Standard Error 3.587
Indacaterol Acetate 150 µg	Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.	Morning 4 weeks - <8 weeks (n=104,100,109)	338.23 liters/second	Standard Error 4.466
Placebo	Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.	Evening baseline - <4 weeks (n=104,100,109)	312.42 liters/second	Standard Error 3.545
Placebo	Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.	Morning 4 weeks - <8 weeks (n=104,100,109)	315.60 liters/second	Standard Error 4.248
Placebo	Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.	Evening 8 weeks - <12 weeks (n=104,100,109)	316.28 liters/second	Standard Error 4.677
Placebo	Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.	Evening 4 weeks - <8 weeks (n=104,100,109)	313.31 liters/second	Standard Error 4.284
Placebo	Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.	Morning Baseline - <4 weeks (n=104,100,109)	307.68 liters/second	Standard Error 3.636
Placebo	Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.	Morning 8 weeks - <12 weeks (n=104,100,109)	317.03 liters/second	Standard Error 4.559

Secondary

Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)

Peak Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Peak FEV1 is defined as the maximum FEV1 during the first 4 h post morning dosing at Day 1, 2Weeks and 12 Weeks.

Time frame: Day 1, 2 weeks (Day 14), 12 weeks (Day 84)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Indacaterol Acetate 75 µg	Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)	Day 14	2.345 liters	Standard Error 0.0252
Indacaterol Acetate 75 µg	Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)	Day 1	2.287 liters	Standard Error 0.0183
Indacaterol Acetate 75 µg	Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)	Day 84	2.345 liters	Standard Error 0.0272
Indacaterol Acetate 150 µg	Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)	Day 14	2.387 liters	Standard Error 0.0254
Indacaterol Acetate 150 µg	Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)	Day 1	2.353 liters	Standard Error 0.0182
Indacaterol Acetate 150 µg	Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)	Day 84	2.403 liters	Standard Error 0.0273
Placebo	Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)	Day 1	2.172 liters	Standard Error 0.0176
Placebo	Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)	Day 84	2.215 liters	Standard Error 0.027
Placebo	Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)	Day 14	2.165 liters	Standard Error 0.0248

Secondary

Plasma Indacaterol Concentrations at Day 1 and Day 14

Maximum plasma concentration after drug administration (Cmax) was measured for indacaterol acetate 75 µg and indacaterol acetate 150 µg for Pharmacokinetic (PK) Subgroup

Time frame: Day 1 and Day 14

Population: Pharmacokinetic (PK) profiling subgroup included all randomized patients who consented to participate in the additional PK assessment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Indacaterol Acetate 75 µg	Plasma Indacaterol Concentrations at Day 1 and Day 14	Day 1 (n=21, 21)	70.7 pg/ml	Standard Deviation 29.1
Indacaterol Acetate 75 µg	Plasma Indacaterol Concentrations at Day 1 and Day 14	Day 14 (n=21, 21)	129 pg/ml	Standard Deviation 48.6
Indacaterol Acetate 150 µg	Plasma Indacaterol Concentrations at Day 1 and Day 14	Day 1 (n=21, 21)	164 pg/ml	Standard Deviation 69.5
Indacaterol Acetate 150 µg	Plasma Indacaterol Concentrations at Day 1 and Day 14	Day 14 (n=21, 21)	285 pg/ml	Standard Deviation 108

Secondary

Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)

Forced Expiratory Volume in 1 second (FEV1)/Area Under the Curve(AUC) was measured via spirometry conducted according to internationally accepted standards.FEV1 AUC(5 min - 4 h), (5 min - 1 h) and (1 h - 4 h) are measured at Day 1, 2 Weeks (Day 14) and 12 Weeks (Day84) and defined as average of FEV1 at specified timepoints above.

Time frame: Day 1, 2 Weeks, 12 Weeks

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Indacaterol Acetate 75 µg	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 14 (5min-4h) (n=107,105,111)	2.265 Liters	Standard Error 0.0244
Indacaterol Acetate 75 µg	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 84 (1h-4h) (n=107,104,111)	2.263 Liters	Standard Error 0.0258
Indacaterol Acetate 75 µg	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 14 (1h-4h) (n=107,104,111)	2.262 Liters	Standard Error 0.0247
Indacaterol Acetate 75 µg	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 14 (5min-1h) (n=107,105,111)	2.267 Liters	Standard Error 0.0245
Indacaterol Acetate 75 µg	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 1 (5min-4h) (n=107,105,111)	2.209 Liters	Standard Error 0.017
Indacaterol Acetate 75 µg	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 84 (5min-1h) (n=107,105,111)	2.265 Liters	Standard Error 0.0271
Indacaterol Acetate 75 µg	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 1 (1h-4h) (n=107,104,111)	2.212 Liters	Standard Error 0.0182
Indacaterol Acetate 75 µg	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 1 (5min-1h) (n=107,105,111)	2.198 Liters	Standard Error 0.0165
Indacaterol Acetate 75 µg	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 84 (5min-4h) (n=107,105,111)	2.264 Liters	Standard Error 0.0259
Indacaterol Acetate 150 µg	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 14 (5min-1h) (n=107,105,111)	2.299 Liters	Standard Error 0.0246
Indacaterol Acetate 150 µg	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 1 (5min-4h) (n=107,105,111)	2.274 Liters	Standard Error 0.0169
Indacaterol Acetate 150 µg	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 1 (5min-1h) (n=107,105,111)	2.253 Liters	Standard Error 0.0164
Indacaterol Acetate 150 µg	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 1 (1h-4h) (n=107,104,111)	2.284 Liters	Standard Error 0.0183
Indacaterol Acetate 150 µg	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 14 (5min-4h) (n=107,105,111)	2.313 Liters	Standard Error 0.0246
Indacaterol Acetate 150 µg	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 14 (1h-4h) (n=107,104,111)	2.318 Liters	Standard Error 0.025
Indacaterol Acetate 150 µg	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 84 (5min-4h) (n=107,105,111)	2.322 Liters	Standard Error 0.026
Indacaterol Acetate 150 µg	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 84 (5min-1h) (n=107,105,111)	2.321 Liters	Standard Error 0.0272
Indacaterol Acetate 150 µg	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 84 (1h-4h) (n=107,104,111)	2.322 Liters	Standard Error 0.026
Placebo	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 1 (1h-4h) (n=107,104,111)	2.082 Liters	Standard Error 0.0175
Placebo	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 1 (5min-4h) (n=107,105,111)	2.077 Liters	Standard Error 0.0163
Placebo	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 84 (5min-4h) (n=107,105,111)	2.132 Liters	Standard Error 0.0257
Placebo	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 1 (5min-1h) (n=107,105,111)	2.059 Liters	Standard Error 0.0158
Placebo	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 84 (1h-4h) (n=107,104,111)	2.130 Liters	Standard Error 0.0257
Placebo	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 14 (5min-1h) (n=107,105,111)	2.069 Liters	Standard Error 0.0241
Placebo	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 14 (5min-4h) (n=107,105,111)	2.074 Liters	Standard Error 0.024
Placebo	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 84 (5min-1h) (n=107,105,111)	2.119 Liters	Standard Error 0.027
Placebo	Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)	Day 14 (1h-4h) (n=107,104,111)	2.066 Liters	Standard Error 0.0244

Secondary

The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period

Annual incidence rate of asthma exacerbation by severity of exacerbation. The number of asthma exacerbation is used to calculate annual incidence rate. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations. Number of the asthma exacerbation will be analyzed by the negative binomial regression including treatment, history of asthma exacerbation in the 12 months prior to screening and region as factors and FEV1 prior to inhalation and FEV1 30 min post inhalation of salbutamol/albuterol (components of SABA reversibility) as covariates. The estimates are obtained from the model and so we cannot specify a formula.

Time frame: 12 weeks

Arm	Measure	Group	Value (NUMBER)
Indacaterol Acetate 75 µg	The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Moderate Asthma Exacerbation	0.225 # of exacerbations
Indacaterol Acetate 75 µg	The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Mild Asthma Exacerbation	0.000 # of exacerbations
Indacaterol Acetate 75 µg	The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Moderate or Severe Exacerbation	0.315 # of exacerbations
Indacaterol Acetate 75 µg	The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Any asthma exacerbation	0.421 # of exacerbations
Indacaterol Acetate 75 µg	The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Severe Asthma Exacerbation	0.000 # of exacerbations
Indacaterol Acetate 150 µg	The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Mild Asthma Exacerbation	0.001 # of exacerbations
Indacaterol Acetate 150 µg	The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Moderate or Severe Exacerbation	0.353 # of exacerbations
Indacaterol Acetate 150 µg	The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Any asthma exacerbation	0.569 # of exacerbations
Indacaterol Acetate 150 µg	The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Moderate Asthma Exacerbation	0.320 # of exacerbations
Indacaterol Acetate 150 µg	The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Severe Asthma Exacerbation	0.000 # of exacerbations
Placebo	The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Severe Asthma Exacerbation	0.000 # of exacerbations
Placebo	The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Moderate Asthma Exacerbation	0.274 # of exacerbations
Placebo	The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Moderate or Severe Exacerbation	0.352 # of exacerbations
Placebo	The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Mild Asthma Exacerbation	0.001 # of exacerbations
Placebo	The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Any asthma exacerbation	0.788 # of exacerbations

Secondary

The Percentage of Patients Who Permanently Discontinued Study Due to Asthma Exacerbation Over the 12 Week Treatment Period

The percentage of patients who permanently discontinued study due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.

Time frame: 12 weeks

Arm	Measure	Value (NUMBER)
Indacaterol Acetate 75 µg	The Percentage of Patients Who Permanently Discontinued Study Due to Asthma Exacerbation Over the 12 Week Treatment Period	1.9 percentage of participants
Indacaterol Acetate 150 µg	The Percentage of Patients Who Permanently Discontinued Study Due to Asthma Exacerbation Over the 12 Week Treatment Period	1.0 percentage of participants
Placebo	The Percentage of Patients Who Permanently Discontinued Study Due to Asthma Exacerbation Over the 12 Week Treatment Period	3.6 percentage of participants

Secondary

The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period

The percentage of patients with at least one asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.

Time frame: 12 weeks

Arm	Measure	Group	Value (NUMBER)
Indacaterol Acetate 75 µg	The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	moderate asthma exacerbations	4.7 percentage of participants
Indacaterol Acetate 75 µg	The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	mild asthma exacerbations	2.8 percentage of participants
Indacaterol Acetate 75 µg	The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	moderate or severe asthma exacerbations	5.6 percentage of participants
Indacaterol Acetate 75 µg	The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	any asthma exacerbations	8.4 percentage of participants
Indacaterol Acetate 75 µg	The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	severe asthma exacerbations	0.9 percentage of participants
Indacaterol Acetate 150 µg	The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	mild asthma exacerbations	3.8 percentage of participants
Indacaterol Acetate 150 µg	The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	moderate or severe asthma exacerbations	5.7 percentage of participants
Indacaterol Acetate 150 µg	The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	any asthma exacerbations	8.6 percentage of participants
Indacaterol Acetate 150 µg	The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	moderate asthma exacerbations	5.7 percentage of participants
Indacaterol Acetate 150 µg	The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	severe asthma exacerbations	0.0 percentage of participants
Placebo	The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	severe asthma exacerbations	0.9 percentage of participants
Placebo	The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	moderate asthma exacerbations	4.5 percentage of participants
Placebo	The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	moderate or severe asthma exacerbations	4.5 percentage of participants
Placebo	The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	mild asthma exacerbations	5.4 percentage of participants
Placebo	The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	any asthma exacerbations	9.9 percentage of participants

Secondary

The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment

Participants record the number of puffs of rescue medication taken in the previous 12 hours in the morning and nighttime.

Time frame: 12 weeks

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Indacaterol Acetate 75 µg	The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment	Mean Daytime number of puffs (n=103, 99, 100)	0.54 number of puffs	Standard Deviation 0.074
Indacaterol Acetate 75 µg	The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment	Mean daily number of puffs (n=105, 102, 105)	1.08 number of puffs	Standard Deviation 0.132
Indacaterol Acetate 75 µg	The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment	Mean nighttime number of puffs (n=104, 100, 107)	0.55 number of puffs	Standard Deviation 0.063
Indacaterol Acetate 150 µg	The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment	Mean Daytime number of puffs (n=103, 99, 100)	0.55 number of puffs	Standard Deviation 0.077
Indacaterol Acetate 150 µg	The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment	Mean daily number of puffs (n=105, 102, 105)	0.99 number of puffs	Standard Deviation 0.136
Indacaterol Acetate 150 µg	The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment	Mean nighttime number of puffs (n=104, 100, 107)	0.47 number of puffs	Standard Deviation 0.065
Placebo	The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment	Mean daily number of puffs (n=105, 102, 105)	1.31 number of puffs	Standard Deviation 0.132
Placebo	The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment	Mean nighttime number of puffs (n=104, 100, 107)	0.64 number of puffs	Standard Deviation 0.062
Placebo	The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment	Mean Daytime number of puffs (n=103, 99, 100)	0.73 number of puffs	Standard Deviation 0.076

Secondary

Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period

Duration of treatment until first asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is systemic corticosteroids (SCS) use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.

Time frame: 12 weeks

Arm	Measure	Group	Value (MEDIAN)
Indacaterol Acetate 75 µg	Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Moderate Asthma Exacerbation	NA weeks
Indacaterol Acetate 75 µg	Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Mild Asthma Exacerbation	NA weeks
Indacaterol Acetate 75 µg	Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Moderate or Severe exacerbation	NA weeks
Indacaterol Acetate 75 µg	Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Any Asthma Exacerbation	NA weeks
Indacaterol Acetate 75 µg	Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Severe Asthma Exacerbation	NA weeks
Indacaterol Acetate 150 µg	Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Mild Asthma Exacerbation	NA weeks
Indacaterol Acetate 150 µg	Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Moderate or Severe exacerbation	NA weeks
Indacaterol Acetate 150 µg	Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Any Asthma Exacerbation	NA weeks
Indacaterol Acetate 150 µg	Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Moderate Asthma Exacerbation	NA weeks
Indacaterol Acetate 150 µg	Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Severe Asthma Exacerbation	NA weeks
Placebo	Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Severe Asthma Exacerbation	NA weeks
Placebo	Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Moderate Asthma Exacerbation	NA weeks
Placebo	Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Moderate or Severe exacerbation	NA weeks
Placebo	Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Mild Asthma Exacerbation	NA weeks
Placebo	Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period	Any Asthma Exacerbation	NA weeks

Secondary

Time to Permanent Study Discontinuation Due to Asthma Exacerbation Over the 12 Week Treatment Period

Time to permanent study discontinuation due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.

Time frame: 12 weeks

Arm	Measure	Value (MEDIAN)
Indacaterol Acetate 75 µg	Time to Permanent Study Discontinuation Due to Asthma Exacerbation Over the 12 Week Treatment Period	NA days
Indacaterol Acetate 150 µg	Time to Permanent Study Discontinuation Due to Asthma Exacerbation Over the 12 Week Treatment Period	NA days
Placebo	Time to Permanent Study Discontinuation Due to Asthma Exacerbation Over the 12 Week Treatment Period	NA days

Secondary

Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period

Total amounts (in doses) of systemic corticosteroids (SCS) used to treat asthma exacerbations.SCS includes Intramuscular (IM), Intravenous (IV) and Oral. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.

Time frame: 12 weeks

Arm	Measure	Group	Value (MEAN)	Dispersion
Indacaterol Acetate 75 µg	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Intravenous- Hydrocortisone NA Succinate	300 milligrams (mg)	—
Indacaterol Acetate 75 µg	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Oral - Prednisone equivalent dose	102 milligrams (mg)	Standard Deviation 66.765
Indacaterol Acetate 75 µg	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Oral- Methylprednisolone	NA milligrams (mg)	—
Indacaterol Acetate 75 µg	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Intravenous- Methylprednisolone NA Succinate	60 milligrams (mg)	Standard Deviation 28.284
Indacaterol Acetate 75 µg	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	IIntramuscular - Triamcinolone Acetonide	NA milligrams (mg)	—
Indacaterol Acetate 75 µg	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Oral - Prednisone	40 milligrams (mg)	—
Indacaterol Acetate 75 µg	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Intravenous- Hydrocortisone	500 milligrams (mg)	—
Indacaterol Acetate 75 µg	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Intravenous - Betamethasone	NA milligrams (mg)	—
Indacaterol Acetate 75 µg	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Oral - Prednisolone	60 milligrams (mg)	Standard Deviation 42.426
Indacaterol Acetate 150 µg	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Intravenous- Methylprednisolone NA Succinate	80 milligrams (mg)	—
Indacaterol Acetate 150 µg	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	IIntramuscular - Triamcinolone Acetonide	20 milligrams (mg)	—
Indacaterol Acetate 150 µg	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Intravenous - Betamethasone	4 milligrams (mg)	—
Indacaterol Acetate 150 µg	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Intravenous- Hydrocortisone	100 milligrams (mg)	—
Indacaterol Acetate 150 µg	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Intravenous- Hydrocortisone NA Succinate	500 milligrams (mg)	Standard Deviation 141.421
Indacaterol Acetate 150 µg	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Oral- Methylprednisolone	32 milligrams (mg)	—
Indacaterol Acetate 150 µg	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Oral - Prednisolone	90 milligrams (mg)	—
Indacaterol Acetate 150 µg	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Oral - Prednisone	40 milligrams (mg)	Standard Deviation 0
Indacaterol Acetate 150 µg	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Oral - Prednisone equivalent dose	106.11 milligrams (mg)	Standard Deviation 104.055
Placebo	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Intravenous- Hydrocortisone	200 milligrams (mg)	—
Placebo	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	IIntramuscular - Triamcinolone Acetonide	0 milligrams (mg)	—
Placebo	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Oral - Prednisolone	37.50 milligrams (mg)	Standard Deviation 24.749
Placebo	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Intravenous - Betamethasone	4 milligrams (mg)	—
Placebo	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Oral - Prednisone equivalent dose	58.61 milligrams (mg)	Standard Deviation 49.956
Placebo	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Intravenous- Methylprednisolone NA Succinate	NA milligrams (mg)	—
Placebo	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Intravenous- Hydrocortisone NA Succinate	NA milligrams (mg)	—
Placebo	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Oral - Prednisone	100 milligrams (mg)	Standard Deviation 70.11
Placebo	Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period	Oral- Methylprednisolone	NA milligrams (mg)	—

Secondary

Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.

Time frame: Day 15, Day 29 and Day 57

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Indacaterol Acetate 75 µg	Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.	Day 29	2.180 Liters	Standard Error 0.0274
Indacaterol Acetate 75 µg	Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.	Day 15	2.169 Liters	Standard Error 0.0259
Indacaterol Acetate 75 µg	Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.	Day 57	2.180 Liters	Standard Error 0.0281
Indacaterol Acetate 150 µg	Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.	Day 29	2.196 Liters	Standard Error 0.0276
Indacaterol Acetate 150 µg	Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.	Day 15	2.198 Liters	Standard Error 0.026
Indacaterol Acetate 150 µg	Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.	Day 57	2.227 Liters	Standard Error 0.0281
Placebo	Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.	Day 15	2.069 Liters	Standard Error 0.0253
Placebo	Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.	Day 57	2.099 Liters	Standard Error 0.0273
Placebo	Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.	Day 29	2.057 Liters	Standard Error 0.0266

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026

Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85)

Asthma Control Questionnaire 5 (ACQ-5) After 12 Weeks (Day 85)

Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment

Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment

Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period

Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85

Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85

Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points

Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.

Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)

Plasma Indacaterol Concentrations at Day 1 and Day 14

Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)

The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period

The Percentage of Patients Who Permanently Discontinued Study Due to Asthma Exacerbation Over the 12 Week Treatment Period

The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period

The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment

Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period

Time to Permanent Study Discontinuation Due to Asthma Exacerbation Over the 12 Week Treatment Period

Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period

Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.