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

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Bromides; Glycopyrrolate; Tiotropium Bromide

Criteria

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