Trial | NCT01127048  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    Ivy leaf ...

  • Study Participants

    1400
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.
Study Started
Oct 31
2008
Primary Completion
Aug 31
2013
Anticipated
Study Completion
Aug 31
2013
Anticipated
Last Update
Jun 15
2011
Estimate

Drug Placebo

Suppositories containing no Ivy leaves dry extract

Drug Suppositories containing Ivy leaves dry extract

Suppositories containing Ivy leaves dry extract

  • Other names: Prospan® Hustenzäpfchen

Prospan Hustenzäpfchen Experimental

Placebo Placebo Comparator

Criteria 

Inclusion Criteria:

male or female children aged 0 to 6 years
acute bronchitis existing not longer than three days and accompanied by coughing
symptom rating score of ≥ 5 assessed by the investigator
symptom 'frequency of coughing' of ≥ 2 assessed by the investigator
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 -

Exclusion Criteria:

hypersensitivity to the active ingredient or to any further constituents of the pharmaceutical preparations
patients with severe allergies or multiple drug allergies
any other pulmonary disease within the last two weeks
chronic pulmonary diseases
exacerbation of chronic pulmonary disease
suspicion of bacterial pulmonary infection
fever above 39°C (rectal measurement) -
No Results Posted