The Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

A Multicenter, Randomized, Blinded, Double-dummy, Placebo-controlled, 3-period Cross-over Study to Evaluate the Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control

This study assessed the effect of QVA149 on patient-reported dyspnea in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.

This study used a multi-center, randomized, blinded, double-dummy placebo controlled, three-period crossover design to assess the effect of once daily QVA149 q.d vs. placebo and tiotropium 18 μg q.d. in terms of patient reported dyspnea as assessed by Baseline Dyspnea Index (BDI)/Transient Dyspnea Index (TDI)(SAC version) in patients with moderate to severe COPD.

Inclusion Criteria:

• Patients with moderate to severe stable chronic obstructive pulmonary disease
• Smoking history of 10 pack years
• Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) between 30 - 80%
• Patients must be able to use computer mouse and display
• mMRC grade>2

Exclusion Criteria:

• Patients with a history of long QT syndrome
• Patients with Type I or uncontrolled Type II diabetes
• Patients who have had a COPD exacerbation or respiratory tract infection within 6 weeks prior to screening
• Patients with any history of asthma
• Patients with pulmonary lobectomy, lung volume reduction surgery, or lung transplantation
• Patients with concomitant pulmonary disease
• Patients requiring long term oxygen therapy (>15 h a day)

Other protocol-defined inclusion/exclusion criteria may apply.