the hero-study: effects of roflumilast in patients with copd (chronic obstructive pulmonary disease) (by217/m2-121)

Conditions: Chronic Obstructive Pulmonary Disease, COPD

Summary: the purpose of this trial is to study the effects of roflumilast on lung function parameters indicative of hyperinflation in patients with copd.


Eligibility criteria:
main inclusion criteria: * written informed consent * patients with a history of chronic obstructive pulmonary disease for at least 12 months as defined by the gold (global initiative on obstructive lung diseases) criteria (2003) * age ≥ 40 years * fev1/fvc ratio (post-bronchodilator) ≤ 70% * fev1 (post-bronchodilator) ≤ 65% of predicted * frc (post-bronchodilator) ≤ 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). main 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 * 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) * current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 2 months preceding the baseline visit (b0). * known alpha-1-antitrypsin deficiency * need for long term oxygen therapy defined as ≥ 15 hours/day * clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator) * 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 * the female patient is of childbearing potential and is not using and is not willing to continue to use a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless she is surgically sterilized/hysterectomized or post-menopausal \> 1 year or any other criteria considered sufficiently reliable by the investigator in individual cases * 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 * suspected inability or unwillingness to comply with study procedures * alcohol or drug abuse * inability to follow study procedures due to, for example, language problems or psychological disorders * use of prohibited drugs * suspected hypersensitivity to the study medication and/or contraindication to any ingredients of the study medication (roflumilast) or rescue medication