Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52 Weeks Double Blind Study With 500mcg Roflumilast Once Daily Versus Placebo. Ratio-Study.
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 pulmonary disease (COPD).
Status | Completed |
Enrollment | 1100 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Main Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | ALTANA Pharma | Cities in Australia | |
Austria | ALTANA Pharma | Cities in Austria | |
Canada | ALTANA Pharma | Cities in Canada | |
France | ALTANA Pharma | Cities in France | |
Hungary | ALTANA Pharma | Cities in Hungary | |
Italy | ALTANA Pharma | Cities in Italy | |
Netherlands | ALTANA Pharma | Cities in the Netherlands | |
Poland | ALTANA Pharma | Cities in Poland | |
Portugal | ALTANA Pharma | Cities in Portugal | |
Russian Federation | ALTANA Pharma | Cities in the Russian Federation | |
South Africa | ALTANA Pharma | Cities in South Africa | |
Spain | ALTANA Pharma | Cities in Spain | |
Switzerland | ALTANA Pharma | Cities in Switzerland | |
United Kingdom | ALTANA Pharma | Cities in the United Kingdom |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Australia, Austria, Canada, France, Hungary, Italy, Netherlands, Poland, Portugal, Russian Federation, South Africa, Spain, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The frequency of patients experiencing at least one moderate or severe exacerbation during the treatment period. | |||
Primary | Change in FEV1 from baseline during the treatment period. | |||
Secondary | Pulmonary function variables; quality of life variables;patient diary variables;safety |
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