Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00669617
• Collaborator: (none)
• Enrollment: 89
• Locations: 17
• Arms: 5
• Duration (Months): 4
• Patients Per Site: 5.2
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

This study will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to placebo, salbutamol 200 µg and salmeterol/fluticasone 50/500 µg

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Indacaterol; Drug: Salmeterol/fluticasone (50/500 μg); Drug: Salbutamol (200 µg); Drug: Placebo to Indacaterol; Drug: Placebo to Salmeterol/fluticasone; Drug: Placebo to salbutamol	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 89 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase III, Randomized, Double-blind, Triple-dummy, Placebo Controlled, Multicenter, 5-period, Single-dose Complete Block Crossover Study to Determine the Onset of Action of Indacaterol (150 and 300 μg) in Patients With Moderate to Severe COPD Using Salbutamol (200 μg) and Salmeterol/Fluticasone (50/500 μg) as Active Controls
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ind 150μg, Salm/flut, Ind 300μg, Placebo, Salbut Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut), Indacaterol 300 μg (Ind 300μg), Placebo, Salbutamol 200 μg (Salbut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Drug: Indacaterol; Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI); Other Names: Arcapta Neohaler ; Drug: Salmeterol/fluticasone (50/500 μg); Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).; Drug: Salbutamol (200 µg); Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).; Drug: Placebo to Indacaterol; Placebo to indacaterol delivered via SDDPI; Drug: Placebo to Salmeterol/fluticasone; Placebo to salmeterol/fluticasone delivered via MDDPI; Drug: Placebo to salbutamol; Placebo to salbutamol delivered via MDDPI
Experimental: Ind 300μg, Ind 150μg, Salbut, Salm/flut, Placebo Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo. At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Drug: Indacaterol; Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI); Other Names: Arcapta Neohaler ; Drug: Salmeterol/fluticasone (50/500 μg); Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).; Drug: Salbutamol (200 µg); Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).; Drug: Placebo to Indacaterol; Placebo to indacaterol delivered via SDDPI; Drug: Placebo to Salmeterol/fluticasone; Placebo to salmeterol/fluticasone delivered via MDDPI; Drug: Placebo to salbutamol; Placebo to salbutamol delivered via MDDPI
Experimental: Salm/flut, Placebo, Ind 150μg, Salbut, Ind 300μg Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo, Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Drug: Indacaterol; Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI); Other Names: Arcapta Neohaler ; Drug: Salmeterol/fluticasone (50/500 μg); Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).; Drug: Salbutamol (200 µg); Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).; Drug: Placebo to Indacaterol; Placebo to indacaterol delivered via SDDPI; Drug: Placebo to Salmeterol/fluticasone; Placebo to salmeterol/fluticasone delivered via MDDPI; Drug: Placebo to salbutamol; Placebo to salbutamol delivered via MDDPI
Experimental: Salbut, Ind 300μg, Placebo, Ind 150μg, Salm/flut Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg), Placebo, Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Drug: Indacaterol; Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI); Other Names: Arcapta Neohaler ; Drug: Salmeterol/fluticasone (50/500 μg); Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).; Drug: Salbutamol (200 µg); Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).; Drug: Placebo to Indacaterol; Placebo to indacaterol delivered via SDDPI; Drug: Placebo to Salmeterol/fluticasone; Placebo to salmeterol/fluticasone delivered via MDDPI; Drug: Placebo to salbutamol; Placebo to salbutamol delivered via MDDPI
Experimental: Placebo, Salbut, Salm/flut , Ind 300μg, Ind 150μg Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Placebo, Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/flut), Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Drug: Indacaterol; Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI); Other Names: Arcapta Neohaler ; Drug: Salmeterol/fluticasone (50/500 μg); Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).; Drug: Salbutamol (200 µg); Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).; Drug: Placebo to Indacaterol; Placebo to indacaterol delivered via SDDPI; Drug: Placebo to Salmeterol/fluticasone; Placebo to salmeterol/fluticasone delivered via MDDPI; Drug: Placebo to salbutamol; Placebo to salbutamol delivered via MDDPI

Outcome Measures

Primary Outcome Measures

1. Forced Expiratory Volume in 1 Second (FEV1) at 5 Minutes Post-dose [Five Minutes Post Dose]

   FEV1 was measured at 5 minutes after dosing with spirometry conducted according to internationally accepted standards. The time of dosing was defined as the time corresponding to the use of the first inhaler device. The primary variable was analyzed using a mixed model containing the period baseline FEV1 as covariate. The period baseline FEV1 was the average of the FEV1 value measured in the clinic at 50 and 15 min prior to the study drug administration in that period.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male and female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure

• Patients with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the GOLD Guidelines, 2006) and:

• Smoking history of at least 20 pack years

• Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) <80% and ≥30% of the predicted normal value.

• Post-bronchodilator FEV1/Forced Vital Capacity (FVC) < 70%, where FVC is forced vital capacity ('Post-' refers to 15-30 minutes after inhalation of 400 μg of salbutamol at Visit 2)

Exclusion Criteria:

• Pregnant / nursing women or women of child-bearing potential

• Long term oxygen therapy (more than 15 hours per day) on a daily basis for chronic hypoxemia

• Patients hospitalized for COPD exacerbation in 6 weeks prior to Visit 2 and up to Visit 3

• Respiratory tract infection within 6 weeks prior to Visit 2 and up to Visit 3

• Concomitant pulmonary disease, pulmonary tuberculosis (unless chest x-ray confirms no longer active) or clinically significant bronchiectasis

• Any history of asthma, including: blood eosinophil count >400/mm3; onset of asthma symptoms prior to age 40 years

• History of long QT syndrome or whose QTc (Bazett's) measured at Visit 2 or Visit 3 is prolonged (>450ms for males or >470ms for females)

• Clinically relevant lab abnormalities / conditions such as (but not limited to) unstable ischemic heart disease, arrhythmia (excluding stable AF), uncontrolled hypertension, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which in the investigator's opinion might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study

• Uncontrolled Type I / Type II Diabetes or blood glucose outside normal or HbA1c >8.0% of total hemoglobin measured at Visit 2

• Any patient with lung cancer or any active cancer or a history of cancer with less than 5 years disease-free survival time

• History of hypersensitivity to any of the study drugs

• Irregular day/night, waking/sleeping cycles e.g. shift workers

• Live attenuated vaccinations within 30 days prior to Visit 2

• Investigational drug within 30 days prior to Visit 2

• Known history of non-compliance or not able to use devices or perform spirometry

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Tamarac	Florida	United States	33321
2	Novartis Investigator Site	Lafayette	Louisiana	United States	70503
3	Novartis Investigative Site	St Charles	Missouri	United States	63301-2847
4	Novartis Investigative site	Shelby	North Carolina	United States	28150
5	Novartis Investigative Site	Beaver	Pennsylvania	United States	15009
6	Novartis Investigative Site	Antwerpen		Belgium
7	Novartis Investigative Site	Berlin		Germany
8	Novartis Investigator Site	Borstel		Germany
9	Novartis Investigative site	Dortmund		Germany
10	Novartis Investigative site	Hamburg		Germany
11	Novartis Investigative site	Hannover		Germany
12	Novartis Investigative site	Mainz		Germany
13	Novartis Investigator Site	Potsdam		Germany
14	Novartis Investigative site	Wiesbaden		Germany
15	Novartis Investigative site	Debrecen		Hungary
16	Novartis Investigative site	Deszk		Hungary
17	Novartis Investigative Site	Nyiregyhaza		Hungary

Sponsors and Collaborators

• Novartis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00669617
• Other Study ID Numbers: CQAB149B2307; EUDRACT: 2007-006189-14
• First Posted: Apr 30, 2008
• Last Update Posted: Sep 12, 2011
• Last Verified: Sep 1, 2011

• Keywords provided by , ,: chronic obstructive pulmonary disease; COPD; indacaterol; adults
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Fluticasone; Xhance; Albuterol; Salmeterol Xinafoate

Study Results

Participant Flow

Arm/Group Title	Ind 150μg, Salm/Flut, Ind 300μg, Placebo, Salbut	Ind 300μg, Ind 150μg, Salbut, Salm/Flut, Placebo	Salm/Flut, Placebo, Ind 150μg, Salbut, Ind 300μg	Salbut, Ind 300μg, Placebo, Ind 150μg, Salm/Flut	Placebo, Salbut, Salm/Flut , Ind 300μg, Ind 150μg
Arm/Group Description	Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut), Indacaterol 300 μg (Ind 300μg), Placebo, Salbutamol 200 μg (Salbut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo. At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo, Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg), Placebo, Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Placebo, Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/Flut), Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Period Title: Period 1
STARTED	18	17	18	18	18
COMPLETED	18	17	17	18	17
NOT COMPLETED	0	0	1	0	1
Period Title: Period 1
STARTED	18	17	17	18	17
COMPLETED	18	17	17	18	17
NOT COMPLETED	0	0	0	0	0
Period Title: Period 1
STARTED	18	17	17	18	17
COMPLETED	17	17	17	18	17
NOT COMPLETED	1	0	0	0	0
Period Title: Period 1
STARTED	17	17	17	18	17
COMPLETED	17	17	17	18	17
NOT COMPLETED	0	0	0	0	0
Period Title: Period 1
STARTED	17	17	17	18	17
COMPLETED	17	17	17	18	17
NOT COMPLETED	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Total Population
Arm/Group Description	Participants were randomized to one of five treatment sequences. Each treatment sequence comprised 5 double-blind, single dose treatment periods (Periods I to V), separated by a washout period of 4-7 days. Participants received each of the 5 blinded-treatments: indacaterol 150 μg, indacaterol 300 μg, salmeterol/fluticasone 50/500 μg, salbutamol 200 μg and placebo.
Overall Participants	89
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.3 (8.37)
Sex: Female, Male (Count of Participants)
Female	35 39.3%
Male	54 60.7%

Outcome Measures

1. Primary Outcome

Title	Forced Expiratory Volume in 1 Second (FEV1) at 5 Minutes Post-dose
Description	FEV1 was measured at 5 minutes after dosing with spirometry conducted according to internationally accepted standards. The time of dosing was defined as the time corresponding to the use of the first inhaler device. The primary variable was analyzed using a mixed model containing the period baseline FEV1 as covariate. The period baseline FEV1 was the average of the FEV1 value measured in the clinic at 50 and 15 min prior to the study drug administration in that period.
Time Frame	Five Minutes Post Dose

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat (mITT) population: including all randomized patients who received at least one dose of study drug. If any of the values used in the period baseline FEV1 and FEV1 at 5 min post-dose were collected within 6 hours of rescue medication, then the individual FEV1 value was set to missing.

Arm/Group Title	Indacaterol 150 µg	Indacaterol 300 µg	Placebo	Salmeterol/Fluticasone	Salbutamol
Arm/Group Description	Participants received a single dose of Indacaterol 150 µg delivered via a Single-Dose Dry-Powder Inhaler (SDDPI), placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and placebo to salbutamol delivered via MDDPI. Each treatment period lasted up to 2 hours following study drug administration and was separated from the previous treatment by a washout period of 4 to 7 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Participants received a single dose of Indacaterol 300 µg delivered via a Single-Dose Dry-Powder Inhaler (SDDPI), a placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and a placebo to salbutamol delivered via MDDPI. Each treatment period lasted up to 2 hours following study drug administration and was separated from the previous treatment by a washout period of 4 to 7 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Participants received placebo to indacaterol delivered via Single-Dose Dry-Powder Inhaler (SDDPI), a placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder (MDDPI) and placebo to salbutamol delivered via MDDPI. Each treatment period lasted up to 2 hours following study drug administration and was separated from the previous one by a washout period of 4 to 7 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Participants received a single dose of Salmeterol/fluticasone 50/500 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Participants received a single dose of Salbutamol 200 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salmeterol/fluticasone delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Measure Participants	85	87	88	88	86
Least Squares Mean (Standard Error) [Liters]	1.48 (0.014)	1.50 (0.014)	1.38 (0.014)	1.43 (0.014)	1.47 (0.014)

Adverse Events

Time Frame	54 days
Adverse Event Reporting Description	Safety population including all patients who received at least one dose of study drug.
Arm/Group Title	Indacaterol 150 µg		Indacaterol 300 µg		Salbutamol		Salmeterol/Fluticasone		Placebo
Arm/Group Description	Participants received a single dose of Indacaterol 150 µg delivered via a Single-Dose Dry-Powder Inhaler (SDDPI), placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.		Participants received a single dose of Indacaterol 300 µg delivered via Single-Dose Dry-Powder Inhaler (SDDPI), a placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.		Participants received a single dose of Salbutamol 200 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salmeterol/fluticasone delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.		Participants received a single dose of Salmeterol/fluticasone 50/500 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.		Participants received placebo to indacaterol delivered via SDDPI, a placebo to salmeterol/fluticasone delivered via MDDPI and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
All Cause Mortality
	Indacaterol 150 µg		Indacaterol 300 µg		Salbutamol		Salmeterol/Fluticasone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Indacaterol 150 µg		Indacaterol 300 µg		Salbutamol		Salmeterol/Fluticasone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/86 (0%)		0/87 (0%)		0/86 (0%)		0/88 (0%)		0/87 (0%)
Other (Not Including Serious) Adverse Events
	Indacaterol 150 µg		Indacaterol 300 µg		Salbutamol		Salmeterol/Fluticasone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/86 (0%)		0/87 (0%)		0/86 (0%)		0/88 (0%)		0/87 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.