Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to investigate the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will last up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast.

For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).

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

Details

• Lead Sponsor: AstraZeneca; Takeda

Criteria

Main Inclusion Criteria:

• COPD patients having at least one exacerbation within last year

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

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

Main Exclusion Criteria:

• COPD exacerbation not resolved at first baseline visit

• Diagnosis of asthma and/or other relevant lung disease