A 24 week, double blind, randomized study to investigate the effect of 500 µg Roflumilast tablets once daily versus placebo on parameters indicative of hyperinflation in patients with chronic obstructive pulmonary disease - HERO
- Conditions
- Chronic obstructive pulmonary disease (COPD)MedDRA version: 5.1Level: LLTClassification code 10010952
- Registration Number
- EUCTR2004-000288-89-ES
- Lead Sponsor
- ALTANA Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 550
- 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 = 70%
- FEV1 (post-bronchodilator) < or = 65% of predicted
- FRC (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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method