Safety and Efficacy of Multiple Doses of QAX028 in Chronic Obstructive Pulmonary Disease (COPD) Patients

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the bronchodilator effects of multiple doses of QAX028 at two different dose levels when compared to tiotropium and placebo in a COPD population.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Tiotropium Bromide

Criteria

Inclusion Criteria:

• Diagnosis of COPD according to GOLD guidelines

• Post-bronchodilator 30%≤FEV1<80% of predicted normal and ost-bronchodilator FEV1/FVC <0.7

• Smoking history of at least 10 pack years

Exclusion Criteria:

• Requiring oxygen therapy on a daily basis

• Exacerbation of airway disease in the 6 weeks prior to screening or between screening and dosing

• Lung reduction surgery

• Respiratory tract infection in the 6 weeks prior to screening

• Significant cardiac history

• History of asthma with onset of symptoms prior to age 40 years

• Active use of certain COPD medications, beta blockers

Other protocol-defined inclusion/exclusion criteria may apply