Chronic obstructive pulmonary disease (COPD) MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Sponsors
Nycomed GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Written informed consent · Age > or =40 years · History of COPD for at least 12 months as defined in the ATS/ERS consensus statement (Standards for the Diagnosis and Management of patients with COPD, 2004) and chronic productive cough for 3 months in each of the 2 years prior to baseline visit V0 (if other causes of productive cough have been excluded) · FEV1/FVC ratio (post-bronchodilator) =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 oral or parenteral glucocorticosteroids and/or hospitalization not resolved at 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) · Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator) · 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 · Chronic gastrointestinal disorders associated with a history of recurrent gastrointestinal bleedings within the last 12 months preceding the baseline visit V0 · Participation in another clinical study (use of investigational product) within 30 days preceding the baseline visit V0 · Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the baseline visit V0 · Use of disallowed drugs · Use of immunosuppressive medications within 4 weeks prior to baseline (e.g. cyclosporine, methotrexate, TNF alpha receptors or antibodies, gold, azothiaprine) · Known alpha-1-antitrypsin deficiency · Known infection with HIV and/or active hepatitis · Diagnosis, treatment, or remission of any cancer (other than basal cell carcinoma) within 5 years prior to study start, · Clinically significant cardiopulmonary abnormalities (diagnosed clinically or by x-ray/CT-scans/ ECG) that are not related to COPD and that require further evaluation · Clinically relevant ECG findings (e.g. acute or recent myocardial infarction, clinically significant arrhythmia) · Alcohol or drug abuse · Suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast) or rescue medication · Patients not able to follow study procedures e.g. language problems, psychological disorders · Suspected non-compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To investigate the safety and tolerability of roflumilast;Main Objective: To investigate the effect of 500 mcg roflumilast once daily on exacerbation rate, pulmonary function, COPD symptoms, dyspnea, health related quality of life and health care resource use;Primary end point(s): Efficacy: Primary variables · Mean change from baseline (V2) during the treatment period in pre-bronchodilator FEV1 · Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids or requiring hospitalization or leading to death, per patient per year Key-secondary variable · Mean change in post-bronchodilator FEV1 from baseline (V2) to each post-randomization visit during the treatment period · Time to mortality due to any reason · Natural log-transformed CRP [mg/L] (mean change from baseline (V2) to last scheduled study visit) · Mean TDI Focal score during the treatment period Secondary variables: COPD exacerbations · Mean rate of all COPD exacerbations per patient per year · Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids per patient per year (excluding hospitalizations and deaths) · Mean rate of COPD exacerbations requiring hospitalization or leading to death per patient per year · Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids or requiring hospitalization or leading to death per patient per year in the population of patients with post-bronchodilator FEV1 or = 2 and a mean sputum score of > or = 2 in the week directly preceding randomization · Proportion of patients experiencing a COPD exacerbation · Time to first COPD exacerbation treated with oral or parenteral steroids or requiring hospitalization or leading to death · Time to first COPD exacerbation treated with oral or parenteral steroids (excluding hospitalizations and deaths) · Time to second COPD exacerbation treated with oral or parenteral steroids or requiring hospitalization or leading to death · Time to second C | — |
Countries
Germany, Italy, Spain
Outcome results
None listed