Prospan® Hustenzäpfchen - Investigation on Efficacy and Tolerability in Children

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

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.

Study Overview

• Status: Unknown
• Conditions: Symptoms of Acute Bronchitis Accompanied by Coughing
• Intervention / Treatment: Drug: Suppositories containing Ivy leaves dry extract; Drug: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 1400
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Manuela Stauss-Grabo, Dr.; Email: m.stauss-grabo@engelhard-am.de

Study Locations

• Germany
  • Niederdorfelden, Germany, 61138
    • Recruiting
    • Engelhard Arzneimittel GmbH & Co. KG
    • Contact: Manuela Stauss-Grabo, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Suppositories containing no Ivy leaves dry extract
Experimental: Prospan Hustenzäpfchen	Drug: Suppositories containing Ivy leaves dry extract; Suppositories containing Ivy leaves dry extract; Other Names: Prospan® Hustenzäpfchen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Engelhard Arzneimittel GmbH & Co.KG
• Investigators: Principal Investigator: Gerhard Zwacka, Prof. Dr.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Anticipated): August 1, 2013
• Study Completion (Anticipated): August 1, 2013

Study Registration Dates

• First Submitted: May 3, 2010
• First Submitted That Met QC Criteria: May 19, 2010
• First Posted (Estimate): May 20, 2010

Study Record Updates

• Last Update Posted (Estimate): June 15, 2011
• Last Update Submitted That Met QC Criteria: June 14, 2011
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: children; bronchitis; coughing; Ivy; Hedera helix L.
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Bronchial Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Cough; Bronchitis
• Other Study ID Numbers: EA-08-1-34