Symptoms of Acute Bronchitis Accompanied by Coughing Clinical Trial
Official title:
Investigation on Efficacy and Tolerability of Prospan® Hustenzäpfchen for the Symptomatic Treatment of Acute Bronchitis Accompanied by Coughing in Children
The aims of this study are
- 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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment