Chronic obstructive pulmonary disease (COPD) MedDRA version: 8.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Product Name: Roflumilast 500 µg tablet
Product Code: BY217
Pharmaceutical Form: Tablet
INN or Proposed INN: Roflumilast
CAS Number: 162401-32-3
Concentration unit: µg microgram(s)
Concentration type:
Sponsors
Nycomed GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Giving written informed consent · Age >= 40 years · History of chronic obstructive pulmonary disease for at least 12 months prior to baseline visit V0 (ATS/ERS 2005) 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) == 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, 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-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, who are 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, intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Please note that female patients who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of childbearing potential · Participation in another study (use of investigational product) within 30 days preceding the baseline visit V0 or re-entry if already enrolled in this trial · Alcohol or drug abuse · Inability to follow study procedures due to e.g. language problems, psychological disorders · Use of disallowed drugs · Suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast or tiotropium) or rescue medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of 500µg roflumilast versus placebo once daily in COPD patients treated with tiotropium;Secondary Objective: To investigate the safety and tolerability of roflumilast in COPD patients treated with tiotropium;Primary end point(s): Mean change from randomization (V2) over 24 weeks of treatment in pre-dose study medication pre-bronchodilator FEV1 | — |
Countries
Austria, Germany, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed