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).
– Chronic Obstructive Pulmonary Disease
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Eligibility & Criteria
Ages Eligible for Study: 40 Years and above, Genders Eligible for Study: BothCriteriaInclusion 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 chest x-ray dated a maximum of 6 months prior to study baseline or a willingness to have a chest x-ray performed at baselineExclusion 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/dayAdditional inclusion/exclusion criteria apply and examination by an investigator is required to determine eligibility
Contact Details Delbert Meyer, M.D., Carmichael, California, 95608, United States; Recruiting
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