Status:
COMPLETED
OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)
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 determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD).
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 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
- 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 :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT00076089
Start Date
December 1 2003
End Date
December 1 2005
Last Update
December 2 2016
Active Locations (40)
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1
ALTANA Pharma
Cities in Alabama, Alabama, United States
2
ALTANA Pharma
Cities in Arizona, Arizona, United States
3
ALTANA Pharma
Cities in Arkansas, Arkansas, United States
4
ALTANA Pharma
Cities in California, California, United States