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

Novartis

Status and phase: Completed; Phase 3

Conditions: COPD

Treatments: Drug: indacaterol and glycopyrronium bromide (QVA149); Drug: tiotropium; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01294787

CQVA149A2305

2010-022721-14 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 85 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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85 participants in 3 patient groups, including a placebo group

indacaterol and glycopyrronium bromide (QVA149)

Experimental group

Description:

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

Treatment:

Drug: indacaterol and glycopyrronium bromide (QVA149)

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo

tiotropium

Active Comparator group

Description:

Tiotropium delivered once daily via HandiHaler® device.

Treatment:

Drug: tiotropium