Status:
COMPLETED
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112)
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease
COPD
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate the effect of 500mcg roflumilast vs placebo on exacerbation rate and pulmonary function as well as quality of life in patients with chronic obstructive pulm...
Eligibility Criteria
Inclusion
- Main
- 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 a chest x-ray dated a maximum of 6 months prior to study baseline visit B0 or a willingness to have a chest x-ray performed before baseline
- Main
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT00430729
Start Date
January 1 2003
Last Update
November 30 2016
Active Locations (14)
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1
ALTANA Pharma
Cities in Australia, Australia
2
ALTANA Pharma
Cities in Austria, Austria
3
ALTANA Pharma
Cities in Canada, Canada
4
ALTANA Pharma
Cities in France, France