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The aims of this study are
- Characterisation of safety and tolerability of Prospan® Hustenzäpfchen in comparison with placebo.
After interim analysis of the first part the clinical study will be continued as follows: Double blind, placebo controlled, randomised, multi-centre study with 2-parallel groups for the treatment of acute bronchitis accompanied by coughing in children aged 0 - 6 years to demonstrate efficacy and safety of Prospan® Hustenzäpfchen.
For assessment of cough intensity and severity a specific symptom score has been developed, which gathers the child's frequency and severity of coughing and of cough productivity as well as the severity of rhonchi (each symptom will be assessed on a four-point Likert scale ranging from 0 to 3; total score range: 0-12 points).
Considering the specificities of the study population and the disease, confirmatory evaluation will be based on the change in the symptom score after the first three consecutive days of treatment as assessed by the investigator.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Symptoms of Acute Bronchitis Accompanied by Coughing
Suppositories containing Ivy leaves dry extract, Placebo
Engelhard Arzneimittel GmbH & Co. KG
Engelhard Arzneimittel GmbH & Co.KG
Published on BioPortfolio: 2014-08-27T03:13:33-0400
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