Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00570778

First received: December 10, 2007

Last updated: January 23, 2013

Last verified: January 2013

History of Changes

Results First Received: October 23, 2012

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

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was 4 arm crossover study. There was a 7 day washout period between each treatment period. 154 patients were randomized, 153 participants received study drug. 5 patients were excluded from the Modified Intent-to-treat population (MITT). 4 patients for protocol violations and 1 patient was randomized but did not receive study drug.

Reporting Groups

	Description
A: Ind 300 μg- Ind 600 μg- Placebo- Ind/Glyc 300/50 μg	Treatment Period 1: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a single dose dry powder inhaler (SDDPI) for 7 days. Treatment Period 2: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days. Treatment Period 3: Two placebo capsules inhaled once daily via a SDDPI for 7 days. Treatment Period 4: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.
B: Ind 600 μg- Placebo- Ind/Glyc 300/50 μg- Ind 300 μg	Treatment Period 1: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days. Treatment Period 2: Two placebo capsules inhaled once daily via a SDDPI for 7 days. Treatment Period 3: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days. Treatment Period 4: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days.
C: Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg- Placebo	Treatment Period 1: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days. Treatment Period 2: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days. Treatment Period 3: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days. Treatment Period 4: Two placebo capsules inhaled once daily via a SDDPI for 7 days.
D: Placebo- Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg	Treatment Period 1: Two placebo capsules inhaled once daily via a SDDPI for 7 days. Treatment Period 2: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days. Treatment Period 3: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days. Treatment Period 4: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.

Participant Flow: Overall Study

	A: Ind 300 μg- Ind 600 μg- Placebo- Ind/Glyc 300/50 μg	B: Ind 600 μg- Placebo- Ind/Glyc 300/50 μg- Ind 300 μg	C: Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg- Placebo	D: Placebo- Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg
STARTED	41	38	37	38
Safety Population: Received Study Drug	41 ^[1]	38	36	38
Modified Intent-to-treat Population	40	37	35	37
COMPLETED	37	34	30	34
NOT COMPLETED	4	4	7	4
Protocol deviation	2	1	2	2
Adverse Event	0	1	4	1
Subject withdrew consent	0	1	0	1
Abnormal test procedure	1	0	0	0
Unsatisfactory therapeutic effect	1	0	0	0
Lost to Follow-up	0	0	1	0
Subject no longer requires study drug	0	1	0	0

[1]	Safety Population included all participants who received at least 1 dose of any study drug.

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Overall Population	Participants were randomized and received the following 4 treatments: 1-Two placebo capsules inhaled once daily via a SDDPI for 7 days, 2-One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days, 3-One Indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days and 4-Two Indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days. There was a 7 day washout period between the four treatment periods.

Description

Overall Population

Participants were randomized and received the following 4 treatments: 1-Two placebo capsules inhaled once daily via a SDDPI for 7 days, 2-One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days, 3-One Indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days and 4-Two Indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days. There was a 7 day washout period between the four treatment periods.

Baseline Measures

	Overall Population
Number of Participants [units: participants]	153
Age ^[1] [units: years] Mean ± Standard Deviation	61.7 ± 8.5
Gender [units: participants]
Female	59
Male	94

[1]	Baseline characteristics are based on the Safety Population that consists of all participants who received study drug.

Outcome Measures

Show All Outcome Measures

1. Primary:

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7 [ Time Frame: Baseline, Day 7 ]

Show Outcome Measure 1

2. Secondary:

Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve (AUC) 5 Minutes-12 Hours at Day 7 [ Time Frame: Day 7 ]

Show Outcome Measure 2

3. Secondary:

Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events [ Time Frame: 47 days ]

Show Outcome Measure 3

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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
No text entered.

Results Point of Contact:

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

No publications provided by Novartis

Publications automatically indexed to this study:

van Noord JA, Buhl R, Laforce C, Martin C, Jones F, Dolker M, Overend T. QVA149 demonstrates superior bronchodilation compared with indacaterol or placebo in patients with chronic obstructive pulmonary disease. Thorax. 2010 Dec;65(12):1086-91. Epub 2010 Oct 26.

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00570778 History of Changes
Other Study ID Numbers:	CQVA149A2204
Study First Received:	December 10, 2007
Results First Received:	October 23, 2012
Last Updated:	January 23, 2013
Health Authority:	United States: Food and Drug Administration Belgium: Federal Agency for Medicinal Products and Health Products Netherlands: Medicines Evaluation Board (MEB) Germany: Federal Institute for Drugs and Medical Devices Canada: Health Canada

To Top