OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD).

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

Details

• Lead Sponsor: AstraZeneca

Criteria

Main Inclusion Criteria:

• FEV1/FVC ratio (post-bronchodilator) ≤70%

• FEV1 (post-bronchodilator) ≤50% of predicted

• Current smoker or ex-smoker

• Clinically stable COPD indicated by no exacerbation and no change in COPD treatment of within 4 weeks prior to baseline

• Availability of chest x-ray dated a maximum of 6 months prior to study baseline or a willingness to have a chest x-ray performed at baseline

Main Exclusion Criteria:

• COPD exacerbation indicated by a treatment with systemic glucocorticoids not stopped 4 weeks prior to baseline

• Lower respiratory tract infection not resolved 4 weeks prior to baseline

• Diagnosis of asthma and/or other relevant lung disease

• Known alpha-1-antitrypsin deficiency

• Need for long-term oxygen therapy defined as ≥16 hours/day