Prospan® Hustenzäpfchen - Investigation on Efficacy and Tolerability in Children

NCT ID: NCT01127048

Last Updated: 2011-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 1400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2013-08-31

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.

Conditions

Symptoms of Acute Bronchitis Accompanied by Coughing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Prospan Hustenzäpfchen

Group Type: EXPERIMENTAL

Suppositories containing Ivy leaves dry extract

Intervention Type: DRUG

Suppositories containing Ivy leaves dry extract

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Suppositories containing no Ivy leaves dry extract

Interventions

Suppositories containing Ivy leaves dry extract

Suppositories containing Ivy leaves dry extract

Intervention Type: DRUG

Placebo

Suppositories containing no Ivy leaves dry extract

Intervention Type: DRUG

Other Intervention Names

Prospan® Hustenzäpfchen

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) -

• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Engelhard Arzneimittel GmbH & Co.KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Robert-Koch-Krankenhaus Apolda

Principal Investigators

Gerhard Zwacka, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Locations

Engelhard Arzneimittel GmbH & Co. KG

Niederdorfelden, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Manuela Stauss-Grabo, Dr.

Role: CONTACT

m.stauss-grabo@engelhard-am.de

Facility Contacts

Manuela Stauss-Grabo, Dr.

Role: primary

Other Identifiers

EA-08-1-34

Identifier Type: -

Identifier Source: org_study_id