Prospan® Hustenzäpfchen - Investigation on Efficacy and Tolerability in Children

Last updated: June 14, 2011
Sponsor: Engelhard Arzneimittel GmbH & Co.KG
Overall Status: Trial Status Unknown

Phase

3

Condition

Bronchitis

Treatment

N/A

Clinical Study ID

NCT01127048
EA-08-1-34
  • Ages < 6
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thesupposed will of the patient, after having been informed about benefits and potentialrisks of the trial, as well as details of the insurance taken out to cover the riskfor patients participating in the study -

Exclusion

Exclusion Criteria:

  1. hypersensitivity to the active ingredient or to any further constituents of thepharmaceutical 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) -

Study Design

Total Participants: 1400
Study Start date:
October 01, 2008
Estimated Completion Date:
August 31, 2013

Study 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.

Connect with a study center

  • Engelhard Arzneimittel GmbH & Co. KG

    Niederdorfelden, 61138
    Germany

    Active - Recruiting

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