500µg roflumilast once daily in combination with 50µg salmeterol twice daily versus 50µg salmeterol twice daily alone over 52 weeks in patients with COPD.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 955

Inclusion Criteria

- Given written informed consent
- Age > or = 40 years
- Patients with a history of moderate or severe chronic obstructive pulmonary disease for at least 12 months prior to baseline visit V0 as defined by the GOLD criteria (2003)
- FEV1/FVC ratio (post-bronchodilator) < 70%
- FEV1 (post-bronchodilator) < or = 60% of predicted
- Fixed airway obstruction (defined as an FEV1 increase of < or = 15% and/or < or = 200 ml after receiving 400 µg salbutamol)
- At least one moderate or severe COPD exacerbation (as defined by the need for systemic glucocorticosteroid and/or antibiotics intake) within one year prior to study baseline visit V0
- Not suffering from any concomitant disease that might interfere with study procedures or evaluation
- Current smoker or former smoker (smoking cessation at least one year ago) with a smoking history of at least 10 pack years
- Availability of a chest x-ray dated a maximum of 6 months prior to study baseline visit V0 or willingness to have a chest x-ray performed at visit V0

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

- COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to the baseline visit V0
- Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit V0
- 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 6 months preceding the baseline visit V0
- Known alpha-1-antitrypsin deficiency
- Need for long-term oxygen therapy defined as = 16 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) 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
- Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized/hysterectomized or post-menopausal > 1 year or who are not using any other method of contraception considered sufficiently reliable by the investigator in individual cases
- Participation in another study (use of investigational product) within 30 days preceding the baseline visit V0 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 e.g. language problems, psychological disorders
- Use of not allowed drugs
- Suspected hypersensitivity to the study medication (roflumilast or salmeterol) or rescue medication, or any other contraindication for the use of salmeterol

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials