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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

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

Criteria

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.