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

NCT ID: NCT01294787

Last Updated: 2013-03-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-11-30

Brief Summary

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This study assessed the effect of once-daily indacaterol and glycopyrronium bromide (QVA149) on exercise endurance in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

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Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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indacaterol and glycopyrronium bromide (QVA149)

QVA149 delivered once daily via single-dose dry powder inhaler.

Group Type EXPERIMENTAL

indacaterol and glycopyrronium bromide (QVA149)

Intervention Type DRUG

placebo

Placebo, delivered once daily via single-dose dry powder inhaler.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

tiotropium

Tiotropium delivered once daily via HandiHaler® device.

Group Type ACTIVE_COMPARATOR

tiotropium

Intervention Type DRUG

Interventions

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indacaterol and glycopyrronium bromide (QVA149)

Intervention Type DRUG

placebo

Intervention Type DRUG

tiotropium

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) stage II or stage III according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines (2009)
* Qualifying spirometry, Forced Expiratory Volume in one second (FEV1) and post-bronchodilator FEV1/FVC (Forced Vital capacity)
* Smoking history ≥ 10 pack years

Exclusion Criteria

* Pregnant women or nursing mothers or women of child-bearing potential not using adequate contraception
* Cardiac abnormality
* History of asthma
* Contraindications to cardiopulmonary exercise testing
* Participation in active phase of pulmonary rehabilitation program
* History of cancer within the past 5 years
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Frankfurt, , Germany

Site Status

Novartis Investigative Site

Großhansdorf, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Lübeck, , Germany

Site Status

Novartis Investigative Site

Mainz, , Germany

Site Status

Novartis Investigative Site

Rudersdorf, , Germany

Site Status

Novartis Investigative Site

Wiesbaden, , Germany

Site Status

Novartis Investigative Site

Alicante, , Spain

Site Status

Novartis Investigative Site

Badalona, , Spain

Site Status

Novartis Investigative Site

Barakaldo, , Spain

Site Status

Novartis Investigative Site

Barcelona, , Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Málaga, , Spain

Site Status

Countries

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Germany Spain

References

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Beeh KM, Korn S, Beier J, Jadayel D, Henley M, D'Andrea P, Banerji D. Effect of QVA149 on lung volumes and exercise tolerance in COPD patients: the BRIGHT study. Respir Med. 2014 Apr;108(4):584-92. doi: 10.1016/j.rmed.2014.01.006. Epub 2014 Jan 21.

Reference Type DERIVED
PMID: 24534204 (View on PubMed)

Other Identifiers

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2010-022721-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQVA149A2305

Identifier Type: -

Identifier Source: org_study_id

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