Trial record 1 of 1 for: NCT01294787.

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Effect of QVA149 on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BRIGHT)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01294787

First received: February 10, 2011

Last updated: March 19, 2013

Last verified: March 2013

History of Changes

Results First Received: November 29, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	COPD
Interventions:	Drug: indacaterol and glycopyrronium bromide (QVA149) Drug: placebo Drug: tiotropium

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study consisted of a maximum 28 day screening period, and three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 85 patients were randomized and 73 patients completed the study. Since this was a cross-over study a participant may be counted in more than 1 group: 77 participants were treated with QVA149, 83 participants treated with tiotropium and 77 participants treated with placebo. One randomized patient did not receive study drug.

Reporting Groups

	Description
QVA149 / Placebo / Tiotropium	Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
QVA149 / Tiotropium / Placebo	Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
Placebo / QVA149 / Tiotropium	Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
Placebo / Tiotropium / QVA149	Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
Tiotropium / QAV149 / Placebo	Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
Tiotropium / Placebo / QVA149	Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.

Participant Flow for 3 periods

Period 1: Period 1

	QVA149 / Placebo / Tiotropium	QVA149 / Tiotropium / Placebo	Placebo / QVA149 / Tiotropium	Placebo / Tiotropium / QVA149	Tiotropium / QAV149 / Placebo	Tiotropium / Placebo / QVA149
STARTED	12	16	14	12	16	15 ^[1]
COMPLETED	12	16	13	11	14	13
NOT COMPLETED	0	0	1	1	2	2
Adverse Event	0	0	0	0	1	0
Withdrawal by Subject	0	0	0	1	1	1
Administrative problem	0	0	1	0	0	1

[1]	One randomized participant did not receive study drug

Period 2: Period 2

	QVA149 / Placebo / Tiotropium	QVA149 / Tiotropium / Placebo	Placebo / QVA149 / Tiotropium	Placebo / Tiotropium / QVA149	Tiotropium / QAV149 / Placebo	Tiotropium / Placebo / QVA149
STARTED	12	16	13	11	14	13
COMPLETED	12	13	13	9	14	13
NOT COMPLETED	0	3	0	2	0	0
Adverse Event	0	3	0	1	0	0
No longer needs study drug	0	0	0	1	0	0

Period 3: Period 3

	QVA149 / Placebo / Tiotropium	QVA149 / Tiotropium / Placebo	Placebo / QVA149 / Tiotropium	Placebo / Tiotropium / QVA149	Tiotropium / QAV149 / Placebo	Tiotropium / Placebo / QVA149
STARTED	12	13	13	9	14	13
COMPLETED	12	13	13	9	13	13
NOT COMPLETED	0	0	0	0	1	0
Adverse Event	0	0	0	0	1	0

Baseline Characteristics

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Reporting Groups

	Description
All Participants	Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods. One participant was randomized but did not receive study drug.

Baseline Measures

	All Participants
Number of Participants [units: participants]	84
Age [units: years] Mean ± Standard Deviation
All participants	62.1 ± 8.11
Gender [units: participants]
Female	53
Male	31

Outcome Measures

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1. Primary:

Exercise Tolerance Comparison Between QVA149 and Placebo Groups [ Time Frame: 3 weeks ]

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2. Secondary:

Dynamic Inspiratory Capacity Comparison Between QVA149 and Placebo Groups [ Time Frame: 3 weeks ]

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3. Secondary:

Trough 24 Hour Post Dose Inspiratory Capacity Comparison Between QVA149 and Placebo Groups [ Time Frame: 3 weeks ]

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4. Secondary:

Trough 24 Hour Post Dose Forced Expiratory Volume in One Second Comparison Between QVA149 and Placebo Groups [ Time Frame: 3 weeks ]

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5. Secondary:

Pulmonary Function Test Comparison Between QVA149 and Placebo Groups [ Time Frame: day 1 and day 21 ]

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6. Secondary:

Pulmonary Function Test (RV) Comparison Between QVA149 and Placebo Groups [ Time Frame: day 1 and day 21 ]

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7. Secondary:

Pulmonary Function Test (SGaw) Comparison Between QVA149 and Placebo Groups [ Time Frame: day 1 and day 21 ]

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8. Secondary:

Pulmonary Function Test (FRC) Comparison Between QVA149 and Placebo Groups [ Time Frame: day 1 and day 21 ]

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9. Secondary:

Spirometry After Three Weeks of Treatment on Patients Not Exercising [ Time Frame: 3 weeks ]

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10. Secondary:

Exertional Dyspnea Comparison Between QVA149 and Placebo Groups [ Time Frame: 3 weeks ]

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11. Secondary:

Leg Discomfort During Exercise Comparison Between QVA149 and Placebo Groups [ Time Frame: 3 weeks ]

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12. Secondary:

Exercise Endurance Comparison Between QVA149 and Tiotropium Groups [ Time Frame: 3 weeks ]

Show Outcome Measure 12

13. Secondary:

Exercise Endurance Time Comparison After a Single Dose of QVA149 Versus Placebo [ Time Frame: Day 1 ]

Show Outcome Measure 13

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 or disclosure of trial results in their entirety.

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: 41 61 324 1111

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01294787 History of Changes
Other Study ID Numbers:	CQVA149A2305, 2010-022721-14
Study First Received:	February 10, 2011
Results First Received:	November 29, 2012
Last Updated:	March 19, 2013
Health Authority:	United States: Food and Drug Administration Germany: Bunesinstitut fur Arzneimittel und Medizinprodukte Agencia Spain: Espanola de medicamentos y productos sanitarios

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