NCT01127048

Prospan® Hustenzäpfchen - Investigation on Efficacy and Tolerability in Children

Investigation on Efficacy and Tolerability of Prospan® Hustenzäpfchen for the Symptomatic Treatment of Acute Bronchitis Accompanied by Coughing in Children

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,400 (estimated)
• Sponsor: Engelhard Arzneimittel GmbH & Co.KG · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Symptoms of Acute Bronchitis Accompanied by Coughing

Interventions

Type	Name	Description
DRUG	Suppositories containing Ivy leaves dry extract	Suppositories containing Ivy leaves dry extract
DRUG	Placebo	Suppositories containing no Ivy leaves dry extract

Timeline

• Start date: 2008-10-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2010-05-20
• Last updated: 2011-06-15

Locations

1 site across 1 country: Germany