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: 100

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
Main Objective: To investigate the effect of 500µg roflumilast once daily in combination with 50µg salmeterol twice daily versus 50µg salmeterol twice daily alone on pulmonary function, exacerbation rate, quality of life and health economics;Secondary Objective: To investigate the safety and tolerability of roflumilast;Primary end point(s): - Mean change from randomization to endpoint in post-bronchodilator FEV1

Secondary Outcome Measures

Name	Time	Method

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