Welcome
Support Centre
23 April 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Efficacy and tolerability of EPs® 7630 in patients with chronic obstructive pulmonary disease (COPD)
ISRCTN ISRCTN01681733
DOI 10.1186/ISRCTN01681733
ClinicalTrials.gov identifier
EudraCT number
Public title Efficacy and tolerability of EPs® 7630 in patients with chronic obstructive pulmonary disease (COPD)
Scientific title 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)
Acronym N/A
Serial number at source 701006.01.001
Study hypothesis To determine the effect of EPs® 7630 (a liquid herbal drug preparation from the roots of Pelargonium sidoides) on time to occurrence of the first acute exacerbation in patients with chronic obstructive pulmonary disease (COPD) compared to placebo.
Lay summary Not provided at time of registration
Ethics approval Ethics Committee and the State Pharmacological Centre of Ukraine approved on the 26/10/2005 (ref: 5.12-408/KE)
Study design Phase III multicentre double-blind randomised placebo-controlled trial
Countries of recruitment Ukraine
Disease/condition/study domain Chronic obstructive pulmonary disease (COPD)
Participants - inclusion criteria 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 N
Participants - exclusion criteria 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
Anticipated start date 13/03/2006
Anticipated end date 16/06/2008
Status of trial Completed
Patient information material
Target number of participants 200
Interventions EPs® 7630 solution or placebo 30 drops three times a day orally for 24 weeks as an add-on therapy to a standardised baseline treatment for COPD.
Primary outcome measure(s) Time to occurrence of first acute exacerbation during the treatment period of 24 weeks.
Secondary outcome measure(s) 1. Number of acute exacerbations during the treatment period of 24 weeks
2. Duration of an acute exacerbation until it has subsided
3. Measurement of FEV1, forced vital capacity (FVC), and FEV1/FVC ratio every 4 weeks for 24 weeks
4. Measurement of FEV1, FVC, and FEV1/FVC ratio at begin and end of an acute exacerbation
5. Health status of the patients using the health-related Quality of Life questionnaire (EQ-5D) and St. George's Respiratory Questionnaire (SGRQ), assessed at baseline and every 4 weeks for 24 weeks
6. Treatment outcome using the Integrative Medicine Outcomes Scale (IMOS), assessed every 4 weeks for 24 weeks
7. Patient's satisfaction with treatment using the Integrative Medicine Patient Satisfaction Scale (IMPSS), assessed every 4 weeks for 24 weeks
8. Duration of limitation of physical activity during an acute exacerbation
9. Duration of patient's inability to work during an acute exacerbation
10. Consumption of paracetamol, Zedex, salmeterol, Berodual N, and budesonide by inhalation during the treatment period of 24 weeks
11. Consumption of salmeterol, budesonide, oral prednisone, Berodual N, and augmentinum (or ofloxacin) during an acute exacerbation
12. Pack year calculation and changes of smoking habits, assessed at baseline and every 4 weeks for 24 weeks
13. Adverse events surveillance: total duration of follow-up: 24 weeks
14. Laboratory values, assessed at baseline and every 4 weeks for 24 weeks
Sources of funding Dr Willmar Schwabe GmbH & Co. KG (Germany)
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23478193
Contact name Dr  Dina A.  Pliskevich
  Address Faculty Therapy No. 2
National Medical University
4 A, Podvisotskogo str.
  City/town Kiev
  Zip/Postcode 01103
  Country Ukraine
Sponsor Dr. Willmar Schwabe GmbH & Co. KG (Germany)
  Address c/o Dr. F. A. Malek
Clinical Research Department
Willmar-Schwabe-Str. 4
  City/town Karlsruhe
  Zip/Postcode 76227
  Country Germany
  Sponsor website: http://www.schwabepharma.com/international/
Date applied 26/03/2009
Last edited 02/10/2013
Date ISRCTN assigned 14/05/2009
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.