Chronic obstructive pulmonary disease (COPD) MedDRA version: 5.1 Level: LLT Classification code 10010952
Conditions
Sponsors
ALTANA Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with a history of chronic obstructive pulmonary disease for at least 12 months as defined by the GOLD criteria (2003) - Age more than 40 years - FEV1/FVC ratio (post-bronchodilator) or = 120% of predicted - Clinically stable COPD within 4 weeks prior to baseline visit B0 - 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 at visit B0 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - COPD exacerbation indicated by a treatment with systemic glucocorticosteroids not stopped at least 4 weeks prior to the baseline visit B0 - Non smoker, current smoker or ex-smoker (smoking cessation at least one year ago) with a smoking history of < 10 pack years (1 One pack year is defined as 20 cigarettes/day for 1 year) - Suffering from any concomitant disease that might interfere with study procedures or evaluation - Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit B0 - Diagnosis of asthma and/or other relevant lung disease (e.g. history of bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease [e.g. fibrosis, silicosis, sarcoidosis], and active tuberculosis) - Known infection with HIV, active hepatitis and/or liver insufficiency - Diagnosis or history of cancer (other than basal cell carcinoma) or recurrence within 5 years prior to study start - Clinically significant cardiopulmonary abnormalities (diagnosed clinically or by x-ray / ECG) that are not related to COPD and that require further evaluation - Pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial - Participation in another study (use of investigational product) within 30 days preceding the baseline visit B0 or re-entry of patients already enrolled in this trial - Alcohol or drug abuse - Suspected hypersensitivity to the study medication and/ or contraindication to any ingredients of the study medication (roflumilast) or rescue medication - known alpha-I-antitrypsin deficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of roflumilast on lung hyperinflation in COPD patients;Secondary Objective: Quality of life, lung function parameters;Primary end point(s): Mean change from randomization to endpoint in post bronchodilator FRCpl | — |
Countries
Spain
Outcome results
None listed