The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the efficacy and safety of QVA149 compared to tiotropium plus formoterol in patients with moderate to severe COPD.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Formoterol Fumarate; Glycopyrrolate; Tiotropium Bromide

Criteria

Inclusion Criteria:

• Male or female adults aged ≥ 40 yrs

• Patients with moderate to severe chronic obstructive pulmonary disease (GOLD 2010 guidelines)

• Smoking history of at least 10 pack years

• Post-bronchodilator FEV1 < 80% and ≥30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%

Exclusion Criteria:

• Pregnant women or nursing mothers or women of child-bearing potential not using adequate contraception

• 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.