Effect of roflumilast in COPD patients treated with salmeterol. A 24 week, double-blind study with 500 g roflumilast once daily versus placebo . Final protocol v.8.0 31 January 2006 - The EOS Study
- Conditions
- Chronic Obstructive Pulmonary Disease COPDMedDRA version: 6.1Level: PTClassification code 10009026
- Registration Number
- EUCTR2005-005080-28-IT
- Lead Sponsor
- ALTANA Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 972
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 FEV1/FVC ratio post-bronchodilator 70 FEV1 post-bronchodilator between 40 and 70 of predicted Fixed airway obstruction defined as an FEV1 increase of 12 or 200 ml after receiving 400 g salbutamol Not suffering from any concomitant disease that might interfere with study procedures or evaluations Current smoker with a smoking history of at least 10 pack years OR former smoker defined as smoking cessation at least one year ago that has a smoking history of at least 10 pack years Availability of a chest x-ray or CT scan 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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effect of 500 g 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): Mean change from randomization V2 in pre-dose study medication pre-bronchodilator FEV1.
- Secondary Outcome Measures
Name Time Method