The trial investigates the effect of 500 µg roflumilast tablets once daily versus placebo on exacerbation rate and pulmonary function in patients with Chronic Obstructive Pulmonary Disease (COPD) who are treatedwith a fixed combination of long-acting ß2-agonists (LABA) and inhaled glucocorticosteroids (ICS). Additionally it provides data on safety and tolerability in COPD patients treated with a fixed combination of LABAand ICS.
- Conditions
- severe chronic obstructive pulmonary disease (COPD)MedDRA version: 14.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2010-019685-87-SK
- Lead Sponsor
- ycomed GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 3002
1. Giving written informed consent
2. History of COPD (according to GOLD 2009) for at least 12 months prior to baseline Visit V0 associated with chronic productive cough for 3 months in each of the 2 years prior to baseline Visit V0 (with other causes of productive cough excluded)
3. Age = 40 years
4. Forced expiratory volume after one second (FEV1)/forced vital capacity (FVC) ratio (post-bronchodilator) < 70%
5. FEV1 (post-bronchodilator) = 50% of predicted
6. At least two documented moderate or severe COPD exacerbations,3
7. Patients must be pre-treated with fixed combinations of LABA and ICS at a constant dose (maximum approved dosage strength of the combination) for at least 12 months prior to baseline Visit V0 separated by at least 10 days, within one year prior to baseline Visit V0
8. Former smoker (defined as smoking cessation at least one year ago) or current smoker both with a smoking history of at least 20 pack years
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3002
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3002
Criteria affecting the read-out parameters of the trial:
1. Moderate or severe COPD exacerbation3 and/or COPD exacerbations treated with antibiotics ongoing at the baseline Visit V0
2. Lower respiratory tract infection not resolved 4 weeks prior to the baseline Visit V0
3. Diagnosis of asthma and/or other relevant lung disease (e.g. history of primary bronchiectases, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease [e.g. fibrosis, silicosis, sarcoidosis], or active tuberculosis)
4. Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the baseline Visit V0
5. Known alpha-1-antitrypsin deficiency
Criteria within ethical considerations in terms of general health:
6. Clinically relevant abnormal laboratory values suggesting an undiagnosed disease requiring further clinical evaluation (as assessed by the Investigator)
7. Severe psychiatric or neurological disorders
8. History of depression associated with suicidal ideation or behaviour
9. Congestive heart failure severity grade IV according to NYHA (New York Heart Association Functional Classification)
10. Haemodynamically significant cardiac arrhythmias or heart valve deformations
11. Computed tomography (CT) or chest x-ray findings indicating an acute pulmonary disease other than COPD (e.g. tuberculosis, severe bronchiectasis, tumours)
12. Severe immunological diseases (e.g. known HIV infection, multiple sclerosis, lupus erythematosus, progressive multifocal leukoencephalopathy)
13. Liver impairment Child-Pugh B or C and/or active viral hepatitis
14. Severe acute infectious diseases (e.g. tuberculosis, or acute hepatitis)
15. Any diagnosis of a malignant disease (except basal cell carcinoma) within 5 years before trial start
16. Alcohol or drug abuse within the past year
17. Suspected hypersensitivity to roflumilast or rescue medication or ingredients thereof, or any other contraindication for the use thereof
18. Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire trial duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized/hysterectomised or post-menopausal > 1 year or who are not using any other method of contraception considered sufficiently reliable by the Investigator in individual cases
19. Pregnancy, breast feeding, planned oocyte donation or oocyte implantation
20. Planned donation of germ cells, blood, organs or bone marrow during the course of the trial
21. Participation in another trial (use of investigational product) within 30 days preceding the baseline Visit V0 or re-entry of patients previously enrolled in this trial
22. Suspected inability or unwillingness to comply with trial procedures (e.g. language problems, psychological disorders, number and timing of visits at the site)
23. Suffering from any concomitant disease that might interfere with trial procedures or evaluations
24. Use of disallowed drugs (see below)
25. Employee at the investigational site, relative or spouse of the Investigator
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