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Prospan® Hustenzäpfchen - Investigation on Efficacy and Tolerability in Children

Primary Purpose

Symptoms of Acute Bronchitis Accompanied by Coughing

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Suppositories containing Ivy leaves dry extract
Placebo
Sponsored by
Engelhard Arzneimittel GmbH & Co.KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptoms of Acute Bronchitis Accompanied by Coughing focused on measuring bronchitis, coughing, children, Ivy, Hedera helix L.

Eligibility Criteria

undefined - 6 Years (Child)All SexesDoes not accept healthy volunteers

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) -

Sites / Locations

  • Engelhard Arzneimittel GmbH & Co. KGRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prospan Hustenzäpfchen

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 3, 2010
Last Updated
June 14, 2011
Sponsor
Engelhard Arzneimittel GmbH & Co.KG
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1. Study Identification

Unique Protocol Identification Number
NCT01127048
Brief Title
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

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Engelhard Arzneimittel GmbH & Co.KG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptoms of Acute Bronchitis Accompanied by Coughing
Keywords
bronchitis, coughing, children, Ivy, Hedera helix L.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prospan Hustenzäpfchen
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Suppositories containing Ivy leaves dry extract
Other Intervention Name(s)
Prospan® Hustenzäpfchen
Intervention Description
Suppositories containing Ivy leaves dry extract
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Suppositories containing no Ivy leaves dry extract
Primary Outcome Measure Information:
Title
Primary outcome measure
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Secondary variables
Description
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
Time Frame
7 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: male or female children aged 0 to 6 years acute bronchitis existing not longer than three days and accompanied by coughing symptom rating score of ≥ 5 assessed by the investigator symptom 'frequency of coughing' of ≥ 2 assessed by the investigator 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: hypersensitivity to the active ingredient or to any further constituents of the pharmaceutical preparations patients with severe allergies or multiple drug allergies any other pulmonary disease within the last two weeks chronic pulmonary diseases exacerbation of chronic pulmonary disease suspicion of bacterial pulmonary infection fever above 39°C (rectal measurement) -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manuela Stauss-Grabo, Dr.
Email
m.stauss-grabo@engelhard-am.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Zwacka, Prof. Dr.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Engelhard Arzneimittel GmbH & Co. KG
City
Niederdorfelden
ZIP/Postal Code
61138
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuela Stauss-Grabo, Dr.

12. IPD Sharing Statement

Learn more about this trial

Prospan® Hustenzäpfchen - Investigation on Efficacy and Tolerability in Children

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