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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Chronic Obstructive Pulmonary Disease
Interventions:	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

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.
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.
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.
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.
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.

Participant Flow for 5 periods

Period 1: Period 1

	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
STARTED	18	17	18	18	18
COMPLETED	18	17	17	18	17
NOT COMPLETED	0	0	1	0	1
Withdrawal by Subject	0	0	1	0	0
Protocol Deviation	0	0	0	0	1

Period 2: Period 2

	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
STARTED	18	17	17	18	17
COMPLETED	18	17	17	18	17
NOT COMPLETED	0	0	0	0	0

Period 3: Period 3

	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
STARTED	18	17	17	18	17
COMPLETED	17	17	17	18	17
NOT COMPLETED	1	0	0	0	0
Lost to Follow-up	1	0	0	0	0

Period 4: Period 4

	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
STARTED	17	17	17	18	17
COMPLETED	17	17	17	18	17
NOT COMPLETED	0	0	0	0	0

Period 5: Period 5

	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
STARTED	17	17	17	18	17
COMPLETED	17	17	17	18	17
NOT COMPLETED	0	0	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Total Population	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.

Baseline Measures

	Total Population
Number of Participants [units: participants]	89
Age [units: years] Mean ± Standard Deviation	62.3 ± 8.37
Gender [units: participants]
Female	35
Male	54

Outcome Measures

1. Primary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00669617 History of Changes
Other Study ID Numbers:	CQAB149B2307, EUDRACT: 2007-006189-14
Study First Received:	April 28, 2008
Results First Received:	July 22, 2011
Last Updated:	September 7, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; United States: Food and Drug Administration