Prospan® Hustenzäpfchen - Investigation on Efficacy and Tolerability in Children

Symptoms of Acute Bronchitis Accompanied by Coughing Clinical Trial

Official title:

Investigation on Efficacy and Tolerability of Prospan® Hustenzäpfchen for the Symptomatic Treatment of Acute Bronchitis Accompanied by Coughing in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01127048
• Other study ID #: EA-08-1-34
• Status: Recruiting
• Phase: Phase 3
• First received: May 3, 2010
• Last updated: June 14, 2011
• Start date: October 2008
• Est. completion date: August 2013

Study information

• Verified date: May 2010
• Source: Engelhard Arzneimittel GmbH & Co.KG
• Contact: Manuela Stauss-Grabo, Dr.
• Email: m.stauss-grabo[@]engelhard-am.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Years

Eligibility

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) -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Disease
• Bronchitis
• Cough
• Symptoms of Acute Bronchitis Accompanied by Coughing

Intervention

Drug:
• Suppositories containing Ivy leaves dry extract
Suppositories containing Ivy leaves dry extract
• Placebo
Suppositories containing no Ivy leaves dry extract

Locations

Country	Name	City	State
Germany	Engelhard Arzneimittel GmbH & Co. KG	Niederdorfelden

Sponsors (1)

Lead Sponsor	Collaborator
Engelhard Arzneimittel GmbH & Co.KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome measure	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.	7 days	No
Secondary	Secondary variables	absolute change of total symptom score; time to response; compliance, defined by drug accountability; percentage of patients requiring concomitant medication for treatment of cough; rates of premature withdrawal; incidence of Adverse Events	7 days	Yes