Chronic obstructive pulmonary disease (COPD) MedDRA version: 8.1 Level: llt Classification code 10010952
Conditions
Sponsors
ALTANA Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Written informed consent · Age > or = 40 years · History of chronic obstructive pulmonary disease for at least 12 months prior to baseline visit V0 (ATS/ERS 2005) · FEV1/FVC ratio (post-bronchodilator) or = 40% and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 3 months preceding the baseline visit V0 · Known alpha-1-antitrypsin deficiency · Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator) · Known infection with HIV and/or active hepatitis · 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 / CT-scan / 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 > 2 years 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of 500µg roflumilast versus placebo once daily in COPD patients treated with salmeterol ;Secondary Objective: To investigate the safety and tolerability of roflumilast in COPD patients treated with salmeterol ;Primary end point(s): Primary variable · Mean change from randomization V2 in pre-dose study medication pre-bronchodilator FEV1 Secondary variables · Mean change from randomization V2 in spirometry parameters · Use of rescue medication (diary cards) and · Symptoms of cough and sputum · BDI/TDI · SOBQ · Exacerbations Safety: · Adverse events · Changes in laboratory values · Changes in vital signs including blood pressure (BP), heart rate (HR) and electrocardiograms (ECG) | — |
Countries
Austria, Germany, Italy, Spain, United Kingdom
Outcome results
None listed