Evaluation of safety and tolerability of Pelargonium sidoides extract EPs®7630 in children (1 to 5 years old) suffering from acute bronchitis
- Conditions
- Acute bronchitisMedDRA version: 14.1Level: LLTClassification code 10000687Term: Acute bronchitisSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2011-002652-14-DE
- Lead Sponsor
- Dr. Willmar Schwabe GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
1. Patient from 1 year to 5 years old.
2. Patient is suffering from acute bronchitis (the patients must have at least two of the three bronchitis-relevant symptoms, i.e. coughing, pulmonary rales at auscultation, and dyspnoea).
3. Patient for whom the legal representatives have given a written informed consent in accordance with the legal requirements.
4. Start of symptoms not longer than 72 hours prior to inclusion into the study
Are the trial subjects under 18? yes
Number of subjects for this age range: 600
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Patient with indication of treatment with antibiotics (e.g. suspected pneumonia)
2. Patient with diagnosed or suspected pneumonia, rhinosinusitis, otitis media, or group
A beta-hemolytic streptococcal (GABHS) tonsillo-pharyngitis
3. Patient with suspicion of foreign body aspiration
4. Known or suspected allergic rhinitis or other allergic diseases
5. History of asthma bronchiale or recurrent bronchitis
6. History of heart, renal, or liver diseases and/or immunosuppression
7. Known or suspected congenital anomalies of heart, kidney, liver, or mental
disabilities
8. Known or suspected hypersensitivity against EPs® 7630 or other excipients of the
investigational products
9. Known or suspected gastro-esophageal reflux disease (GERD)
10. Patient with tendency to bleed, especially nose or gingival bleeding
11. Previous (within the last 6 weeks prior to inclusion into the clinical trial) or
concomitant treatment with anti-coagulants
12. Known or suspected gastrointestinal disorders (e.g. inflammatory bowel disease,
celiac disease, symptomatic lactose intolerance, disbacteriosis, other disorders
associated with diarrhea)
13. Participation in a further clinical trial at the same time or within the last 4 weeks prior
to inclusion into the present study
14. Previous participation in the present clinical study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and tolerability of a treatment with EPs® 7630 syrup in comparison to EPs® 7630 solution in patients between 1 and 5 years old suffering from acute bronchitis.;Secondary Objective: To analyse the health status during the study course. ;Primary end point(s): Safety:<br>- frequency, nature and severity of adverse events<br>- change of vital signs<br>- changes in laboratory values;Timepoint(s) of evaluation of this end point: Adverse events will be assessed during the whole treatment period (7 days of treatment).<br><br>Changes of vital signs will be assessed on day 7 of the study
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Patient’s health status:<br>- Changes in individual respiratory tract infection symptoms related to acute bronchitis as well as the total symptoms score<br>- Treatment outcome using the Integrative Medicine Outcomes Score (IMOS) as assessed by the investigator as well as by the legal representatives of the patients<br>- Satisfaction with the treatment using the Integrative Medicine Patient Satisfaction Scale (IMPSS) as assessed by the legal representatives of the patients.;Timepoint(s) of evaluation of this end point: on day 7 of the study