Acute bronchitis MedDRA version: 14.1 Level: LLT Classification code 10000687 Term: Acute bronchitis System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Umckaloabo®
Product Name: Umckaloabo®
Product Code: EPS® 7630
Pharmaceutical Form: Oral solution
INN or Proposed INN: EPs® 7630
Current Sponsor code: EPs® 7630
Other descriptive name: herb
extraction solvent: ethanol 11% (w/w).
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 80-
Trade Name: Umckaloabo® Saft für Kinder
Product Name: Umck
extraction solvent: ethanol 11% (w/w).
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 0.2506-
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Patient’s health status: - Changes in individual respiratory tract infection symptoms related to acute bronchitis as well as the total symptoms score - Treatment outcome using the Integrative Medicine Outcomes Score (IMOS) as assessed by the investigator as well as by the legal representatives of the patients - 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 | — |
Primary
| Measure | Time frame |
|---|---|
| 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: - frequency, nature and severity of adverse events - change of vital signs - 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). Changes of vital signs will be assessed on day 7 of the study | — |
Countries
Germany
Contacts
Public ContactProject Director
Dr. Willmar Schwabe GmbH & Co. KG
Outcome results
None listed