Effect of roflumilast in COPD patients treated with salmeterol. A 24 week, double blind study with 500 mcg roflumilast once daily versus placebo - EOS
- Conditions
- Chronic obstructive pulmonary disease (COPD)MedDRA version: 8.1Level: lltClassification code 10010952
- Registration Number
- EUCTR2005-005080-28-BE
- 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 > 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 = 70%
· FEV1 (post-bronchodilator) between > or = 40% and < or = 70% of predicted
· Fixed airway obstruction (defined as an FEV1 increase of < or = 12% or < or = 200 ml after receiving 400 µg salbutamol)
· Not suffering from any concomitant disease that might interfere with study procedures or evaluation
· 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 500µg roflumilast versus placebo once daily in COPD patients treated with salmeterol<br>;Secondary Objective: To investigate the safety and tolerability of roflumilast in COPD patients treated with salmeterol<br>;Primary end point(s): Primary variable<br>· Mean change from randomization V2 in pre-dose study medication pre-bronchodilator FEV1<br><br>Secondary variables<br>· Mean change from randomization V2 in spirometry parameters<br>· Use of rescue medication (diary cards) and<br>· Symptoms of cough and sputum<br>· BDI/TDI<br>· SOBQ <br>· Exacerbations<br><br>Safety:<br>· Adverse events<br>· Changes in laboratory values<br>· Changes in vital signs including blood pressure (BP), heart rate (HR) and electrocardiograms (ECG)<br>
- Secondary Outcome Measures
Name Time Method