Phase III study to prove the efficacy and tolerability of EPs® 7630 in patients aged greater than or equal to 18 years old with chronic obstructive pulmonary disease (COPD)

Dr. Willmar Schwabe GmbH & Co. KG (Germany)0 sites200 target enrollmentMay 14, 2009

Overview

No summary available.

Registry

who.int

Start Date

May 14, 2009

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

Dr. Willmar Schwabe GmbH & Co. KG (Germany)

•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