Acute bronchitis accompanied by coughing MedDRA version: 9.1 Level: PT Classification code 10006452 Term: Bronchitis acute
Conditions
Interventions
Trade Name: Prospan® Hustenzäpfchen
Product Name: Prospan® Hustenzäpfchen
Product Code: Prospan® Hustenzäpfchen
Pharmaceutical Form: Suppository
Other descriptive name: ivy leaves dry extract (5-7,5:1
Sponsors
Engelhard Arzneimittel GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. male or female children aged 0 to 6 years 2. acute bronchitis existing not longer than three days and accompanied by coughing 3. symptom rating score of = 5 assessed by the investigator 4. symptom ‘frequency of coughing’ of = 2 assessed by the investigator 5. the patient’s legal representatives must give informed consent in accordance with the supposed will of the patient, after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the risk for patients participating in the study Are the trial subjects under 18? yes Number of subjects for this age range: 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. hypersensitivity to the active ingredient or to any further constituents of the pharmaceutical preparations 2. patients with severe allergies or multiple drug allergies 3. any other pulmonary disease within the last two weeks 4. chronic pulmonary diseases 5. exacerbation of chronic pulmonary disease 6. suspicion of bacterial pulmonary infection 7. fever above 39 °C (rectal measurement) 8. participation in a clinical trial during the last two months prior to the individual enrolment of the patient 9. any systemic treatment with antibiotics or any systemic treatment with immunosuppressives within 2 weeks prior to the first administration 10. impossibility to rectally apply suppositories (e.g. due to rectal injuries, rectal bleeding, anal fissures or fistulas, haemorrhoids, perianal inflammation caused by bacterial or fungal infection, bowel diseases) 11. any hints for presence of haemolysis 12. patients or their legal representatives suspected or known not to follow instructions or not to correctly complete a diary 13. patients or their legal representatives who are unable to understand the written and/or verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: · Demonstrating superior efficacy of Prospan® Hustenzäpfchen compared to Placebo in children suffering from acute bronchitis accompanied by coughing · Characterisation of safety and tolerability of Prospan® Hustenzäpfchen in comparison with placebo;Secondary Objective: -;Primary end point(s): The symptom rating score assessed by the investigator will serve for determination of the primary variable. Baseline will be sum score assessed on visit 1. Effect of treatment as primary variable will be assessed by comparing baseline values to those obtained during visit 2. The primary outcome measure for efficacy will be the relative change in the symptom score between visits 1 and 2 (i. e. between baseline and after the 6th administration i.e. treatment day 3). | — |
Countries
Germany
Outcome results
None listed