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Prospan® Hustenzäpfchen – Investigation on efficacy and tolerability in children: A double-blind, placebo controlled, randomised, multi-centre, comparative study with parallel groups for the symptomatic treatment of acute bronchitis accompanied by coughing in children - Prospan® Hustenzäpfchen – Investigation on efficacy and tolerability in childre

Conditions
Acute bronchitis accompanied by coughing
MedDRA version: 9.1Level: PTClassification code 10006452Term: Bronchitis acute
Registration Number
EUCTR2008-000473-38-DE
Lead Sponsor
Engelhard Arzneimittel GmbH & Co. KG
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
Not specified
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

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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)
8. participation in a clinical trial during the last two months prior to the individual enrolment of the patient
9. any systemic treatment with antibiotics or any systemic treatment with immunosuppressives within 2 weeks prior to the first administration
10. impossibility to rectally apply suppositories (e.g. due to rectal injuries, rectal bleeding, anal fissures or fistulas, haemorrhoids, perianal inflammation caused by bacterial or fungal infection, bowel diseases)
11. any hints for presence of haemolysis
12. patients or their legal representatives suspected or known not to follow instructions or not to correctly complete a diary
13. patients or their legal representatives who are unable to understand the written and/or verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: · Demonstrating superior efficacy of Prospan® Hustenzäpfchen compared to Placebo in children suffering from acute bronchitis accompanied by coughing<br>· Characterisation of safety and tolerability of Prospan® Hustenzäpfchen in comparison with placebo;Secondary Objective: -;Primary end point(s): The symptom rating score assessed by the investigator will serve for determination of the primary variable. <br>Baseline will be sum score assessed on visit 1. Effect of treatment as primary variable will be assessed by comparing baseline values to those obtained during visit 2. The primary outcome measure for efficacy will be the relative change in the symptom score between visits 1 and 2 (i. e. between baseline and after the 6th administration i.e. treatment day 3).<br>
Secondary Outcome Measures
NameTimeMethod
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