Efficacy and tolerability of EPs® 7630 in patients with chronic obstructive pulmonary disease (COPD)
| ISRCTN | ISRCTN01681733 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01681733 |
| Secondary identifying numbers | 701006.01.001 |
- Submission date
- 26/03/2009
- Registration date
- 14/05/2009
- Last edited
- 02/10/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Dina A. Pliskevich
Scientific
Scientific
Faculty Therapy No. 2
National Medical University
4 A, Podvisotskogo str.
Kiev
01103
Ukraine
Study information
| Study design | Phase III multicentre double-blind randomised placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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) |
| Study objectives | 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. |
| Ethics approval(s) | Ethics Committee and the State Pharmacological Centre of Ukraine approved on the 26/10/2005 (ref: 5.12-408/KE) |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease (COPD) |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | EPs® 7630 (Pelargonium sidoides extract) |
| Primary outcome measure | Time to occurrence of first acute exacerbation during the treatment period of 24 weeks. |
| Secondary outcome measures | 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 |
| Overall study start date | 13/03/2006 |
| Completion date | 16/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 13/03/2006 |
| Date of final enrolment | 16/06/2008 |
Locations
Countries of recruitment
- Ukraine
Study participating centre
Faculty Therapy No. 2
Kiev
01103
Ukraine
01103
Ukraine
Sponsor information
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Industry
Industry
c/o Dr. F. A. Malek
Clinical Research Department
Willmar-Schwabe-Str. 4
Karlsruhe
76227
Germany
| Website | http://www.schwabepharma.com/international/ |
|---|---|
"ROR" |
https://ror.org/043rrkc78 |
Funders
Funder type
Industry
Dr Willmar Schwabe GmbH & Co. KG (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2013 | Yes | No |
