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

A Randomized, Blinded, Double Dummy, Multi-center, Placebo Controlled, 3 Period, Crossover Study to Assess the Effect of QVA149 (110/50 µg o.d.) on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control.

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).

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