acute bronchitis MedDRA version: 9.1 Level: PT Classification code 10006452 Term: Bronchitis acute
Conditions
Interventions
Trade Name: Hedelix s.a.
Pharmaceutical Form: Oral drops, solution
Other descriptive name: ivy leaves extract
Concentration unit: g/ml gram(s)/millilitre
Concentration type: equal
Concentration number
Sponsors
Krewel Meuselbach GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient and/or legal guardian is/are able to understand written and/or oral information on the study and has/have given written informed consent prior to participation in the study; in the case of patients not yet of age, but able to understand information on the study, the pa-tient’s consent may be oral, but the consent of the legal guardian/s must be in writing 2. Male or female, Caucasian, at least 2 years of age 3. Confirmed clinical diagnosis of acute bronchitis with a BSS = 5 4. Duration of complaints not more than 48 hours 5. Prepared to comply with the study schedule regarding study medication use, non-use of concomitant medication, and visits 6. In female patients of childbearing potential: negative pregnancy test Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Use of drugs or household remedies for this episode of acute bronchitis 2. Therapy with antibiotics or corticosteroids in the four weeks before the study 3. Use of “cold medications” or “cold prophylactics” during the preceding two weeks 4. Use of antihistamines during the preceding week 5. Use of above medications intended during the study 6. Use of throat lozenges within four hours before the admission examination 7. Use of long-acting beta-2 agonists within 24 hours before the admission examination 8. Use of short-acting beta-2 agonists within eight hours before the admission examination 9. Known hypersensitivity or allergy to ivy leaves extracts 10. Bacterial infection or other indication for therapy with antibiotics 11. Allergic asthma or bronchial hyperreactivity 12. Chronic bronchitis or other chronic or inherited lung diseases 13. Severe cardiac, hepatic, or renal disorders 14. Arginine succinate synthetase deficiency (metabolic disorder of the urea cycle) 15. Evidence of congenital, acquired, or drug or malignancy induced immunodeficiency 16. Previous or concurrent cancer 17. Drug, illicit substance, or alcohol abuse or other factors suggesting questionable compli-ance 18. Pregnancy or lactation 19. Participation in another clinical trial within three months prior to this study 20. Previous participation in this trial 21. Involved in the performance of this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to compare an ivy leaves extract (Hedelix) to an active control (Prospan, another ivy leaves extract). The aim is to establish the efficacy and tolerability in patients with acute bronchitis.;Secondary Objective: ;Primary end point(s): Bronchitis Severity Score (BSS), evaluating the symptoms cough, sputum, rales/rhonchi, chest pain during coughing, and dyspnoea (in-vestigator assessed score, rating each symptom from 0–4) Primary efficacy criterion: Change of BSS on Day 7 vs. baseline | — |
Countries
Czech Republic
Outcome results
None listed