Clinical trial NCT01127048: Prospan® Hustenzäpfchen - Investigation on Efficacy and Tolerability in Children
Official title: Investigation on Efficacy and Tolerability of Prospan® Hustenzäpfchen for the Symptomatic Treatment of Acute Bronchitis Accompanied by Coughing in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Symptoms of Acute Bronchitis Accompanied by Coughing
Keywords: bronchitis
coughing
children
Ivy
Hedera helix L.
Lead sponsor: Engelhard Arzneimittel GmbH & Co.KG
Sponsor class: INDUSTRY
First posted: 2010-05-20
Enrollment: 1400
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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 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:

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

Primary outcomes:
measure: Primary outcome measure
timeFrame: 7 days
Secondary outcomes:
measure: Secondary variables
timeFrame: 7 days
Other outcomes:
Locations:
city: Niederdorfelden
country: Germany
facility: Engelhard Arzneimittel GmbH & Co. KG
Study officials:
name: Gerhard Zwacka, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: