Effect of roflumilast on exacerbation rate in patients with COPD A 52 weeks, double-blind study with 500 mcg roflumilast once daily versus placebo - AURA
- Conditions
- Chronic obstructive pulmonary disease (COPD)MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
- Registration Number
- EUCTR2005-003937-42-GB
- Lead Sponsor
- ALTANA Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1500
· 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) < or= 70%
· FEV1 (post-bronchodilator) < or = 50% of predicted
· At least one documented COPD exacerbation (as defined by the need for oral or parenteral glucocorticosteroid intake and/or hospitalization) within one year prior to study baseline visit V0
· Not suffering from any concomitant disease that might interfere with study procedures or evaluation
· Current smoker or former smoker (smoking cessation at least one year ago) with a smoking history of at least 20 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 or CT-scan 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 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method