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.
Official Title
Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The AURA Study
Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
Study Design
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Further Details
- Primary Outcomes: exacerbation rate; FEV1.
- Secondary Outcomes: other spirometry parameters; COPD symptoms; safety and tolerability of roflumilast.
Study Start
February 2006
Eligibility & Criteria
- Ages Eligible for Study: 40 Years and above
- Genders Eligible for Study: Both
Main Inclusion Criteria:
- COPD patients who have exacerbations
- 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
Total Enrolment
1500 (expected)
Contact Details
ALTANA Pharma, Cities in Australia, Australia; Recruiting
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