Efficacy and tolerability of EPs® 7630 in patients with chronic obstructive pulmonary disease (COPD)

ISRCTN ISRCTN01681733
DOI https://doi.org/10.1186/ISRCTN01681733
Protocol serial number 701006.01.001
Sponsor Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Funder Dr Willmar Schwabe GmbH & Co. KG (Germany)
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

Faculty Therapy No. 2
National Medical University
4 A, Podvisotskogo str.
Kiev
01103
Ukraine

Study information

Primary study designInterventional
Study designPhase III multicentre double-blind randomised placebo-controlled trial
Secondary study designRandomised controlled trial
Scientific titlePhase 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 objectivesTo 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) studiedChronic obstructive pulmonary disease (COPD)
InterventionEPs® 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 typeDrug
PhasePhase III
Drug / device / biological / vaccine name(s)EPs® 7630 (Pelargonium sidoides extract)
Primary outcome measure(s)

Time to occurrence of first acute exacerbation during the treatment period of 24 weeks.

Key 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

Completion date16/06/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration200
Key inclusion criteria1. 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 criteria1. 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 enrolment13/03/2006
Date of final enrolment16/06/2008

Locations

Countries of recruitment

  • Ukraine

Study participating centre

Faculty Therapy No. 2
Kiev
01103
Ukraine

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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
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