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Prospan® Hustenzäpfchen - Investigation on Efficacy and Tolerability in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01127048
Recruitment Status : Unknown
Verified May 2010 by Engelhard Arzneimittel GmbH & Co.KG.
Recruitment status was:  Recruiting
First Posted : May 20, 2010
Last Update Posted : June 15, 2011
Sponsor:
Information provided by:

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.

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

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2008
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Primary outcome measure [ Time Frame: 7 days ]

    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 :
  1. Secondary variables [ Time Frame: 7 days ]
    • 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 20, 2010    Key Record Dates
Last Update Posted: June 15, 2011
Last Verified: May 2010

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