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Prospan® Hustenzäpfchen - Investigation on Efficacy and Tolerability in Children

This study is currently recruiting participants.
Verified May 2010 by Engelhard Arzneimittel GmbH & Co.KG
Sponsor:
Information provided by:
Engelhard Arzneimittel GmbH & Co.KG
ClinicalTrials.gov Identifier:
NCT01127048
First received: May 3, 2010
Last updated: June 14, 2011
Last verified: May 2010
History of Changes
  Purpose

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.

Condition Intervention Phase
Symptoms of Acute Bronchitis Accompanied by Coughing
 Drug: Suppositories containing Ivy leaves dry extract
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation on Efficacy and Tolerability of Prospan® Hustenzäpfchen for the Symptomatic Treatment of Acute Bronchitis Accompanied by Coughing in Children

Resource links provided by NLM:

MedlinePlus related topics: Cough
U.S. FDA Resources

Further study details as provided by Engelhard Arzneimittel GmbH & Co.KG:

Primary Outcome Measures:
  • Primary outcome measure [ Time Frame: 7 days ] [ Designated as safety issue: No ]

    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 [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    • 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


Estimated Enrollment: 1400
Study Start Date: October 2008
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prospan Hustenzäpfchen Drug: Suppositories containing Ivy leaves dry extract
Suppositories containing Ivy leaves dry extract
Other Name: Prospan® Hustenzäpfchen
Placebo Comparator: Placebo Drug: Placebo
Suppositories containing no Ivy leaves dry extract
Other Name: 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.

  Eligibility

Ages Eligible for Study:   up to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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) -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01127048

Contacts
Contact: Manuela Stauss-Grabo, Dr. m.stauss-grabo@engelhard-am.de

Locations
Germany
Engelhard Arzneimittel GmbH & Co. KG Recruiting
Niederdorfelden, Germany, 61138
Contact: Manuela Stauss-Grabo, Dr.            
Sponsors and Collaborators
Engelhard Arzneimittel GmbH & Co.KG
Investigators
Principal Investigator: Gerhard Zwacka, Prof. Dr.
  More Information

No publications provided

Responsible Party: Prof. Dr. Gerhard Zwacka, Robert-Koch-Krankenhaus Apolda
ClinicalTrials.gov Identifier: NCT01127048     History of Changes
Other Study ID Numbers: EA-08-1-34
Study First Received: May 3, 2010
Last Updated: June 14, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Engelhard Arzneimittel GmbH & Co.KG:
bronchitis
coughing
children
Ivy
Hedera helix L.

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Cough
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013