Efficacy and tolerability of EPs® 7630 in patients with chronic obstructive pulmonary disease (COPD)
- Conditions
- Chronic obstructive pulmonary disease (COPD)RespiratoryOther chronic obstructive pulmonary disease
- Registration Number
- ISRCTN01681733
- Lead Sponsor
- Dr. Willmar Schwabe GmbH & Co. KG (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
1. Aged greater than or equal to 18 years, both males and females
2. Written informed consent
3. History of chronic bronchitis (characterised by cough and sputum production on most days for a minimum of 3 months per year for at least 2 consecutive years)
4. Patients with stable COPD (no changes in volume or appearance of sputum or level of dyspnoea in the previous 4 weeks)
5. History of acute exacerbation greater than or equal to 3 times in the prior 12 months
6. Forced expiratory volume during one second (FEV1) less than 80% and greater than or equal to 30% predicted (COPD stage II, III)
7. Improvement of FEV1 during the initial FEV1 reversibility test is less than or equal to 0.3 l after two puffs of Berodual
1. Patients suffering from cardiac diseases, pneumonia, active pulmonary tuberculosis, cystic fibrosis, bronchiectasis, lung cancer, acquired immune deficiency sydrome (AIDS)
2. Patients with asthma bronchiale
3. COPD patients in stage IV (FEV1 less than 30% predicted)
4. Patients with infiltrates or other abnormalities of the lungs indicating an active pathological process on chest x-ray
5. Patients with acute exacerbation within the last 4 weeks
6. Known concomitant bacterial infection or infections of respiratory tract
7. Concomitant medication with beta-blockers, angiotensin converting enzyme (ACE)-inhibitors, regular inhalative glucocorticoids (except in COPD patients stage III), oral glucocorticoids (except during an acute exacerbation), anticholinergics (except ipratropium bromide in Berodual N), beta-2-agonists other than salmeterol or fenoterol in Berodual N, analgetics other than paracetamol, mucolytics and antitussives other than Zedex, immunomodulators (e.g. bacterial vaccines), or coumarin-derivatives
8. Treatment with antibiotics, beta-blockers, ACE-inhibitors, anticholinergics (except ipratropium bromide in Berodual N), inhalative glucocorticoids (except in COPD patients stage III) or oral glucocorticoids within the last 4 weeks prior study inclusion
9. Known alcohol or drug abuse
10. Patients with tendency to bleed
11. Severe heart, renal or liver diseases and/or immunosuppression
12. Gastrointestinal disorders
13. Patients with known or supposed hypersensitivity against EPs® 7630
14. Females of child-bearing potential with no adequate contraception
15. Pregnancy or lactation
16. Patients participating in another clinical trial at the same time or have taken part in a clinical trial during the last 3 months before inclusion into this study
17. Irresponsible patients or those unable to understand nature, meaning and consequences of the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to occurrence of first acute exacerbation during the treatment period of 24 weeks.
- Secondary Outcome Measures
Name Time Method