Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)
Part of paid clinical trials in Fullerton, California.
- Sponsor
- AstraZeneca
- Study ID
- NCT00297102
- Phase
- PHASE3
- Status
- Completed
Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Roflumilast — DRUG500 mcg, once daily, oral administration in the morning
- Placebo — DRUGonce daily
Study Details
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).
Key Dates
- Start date
- Feb 28, 2006
- Status verified
- Sep 2016
- Primary completion
- Jul 31, 2008
- Completion
- Sep 30, 2008
Study Design
- Enrollment
- 1,523 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Roflumilast500 mcg, once daily, oral administration in the morning
- Placebo Comparator: Placeboonce daily
Primary Outcome Measure
Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) [ Time Frame: Change from baseline over 52 weeks of treatment ]
Locations (47)
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Altana Pharma/Nycomed Investigational Site· Fullerton, CAAltana Pharma/Nycomed Investigational Site· Los Angeles, CAAltana Pharma/Nycomed Investigational Site· Palmdale, CAAltana Pharma/Nycomed Investigational Site· Rancho Mirage, CAAltana Pharma/Nycomed Investigational Site· San Diego, CAAltana Pharma/Nycomed Investigational Site· Bay Pines, FL
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