The HERO-study: Effects of Roflumilast in Patients With COPD (Chronic Obstructive Pulmonary Disease) (BY217/M2-121)

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