Tolerance and Effect of a Prophylactical Treatment With Ivy Leaves Dry Extract in Recurrent Wheezy Bronchitis

January 23, 2014 updated by: Technische Universität Dresden

Tolerance and Effect of a Prophylactical Treatment With a Cough Medicine Con-taining Ivy Leaves Dry Extract in Children With Recurrent Wheezy Bronchitis

To evaluate the effect of a prophylactical therapy with a cough medicine containing ivy leaves dry extract on the frequency of recurrent wheezy bronchitis in toddlers, on the duration of the bronchitis episodes, on the severity and the additional drug demand. A prolonged asymptomatic episode between each wheezy bronchitis due to the therapy is assumed.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Saxonia
      • Dresden, Saxonia, Germany, 01307
        • Recruiting
        • Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinder- und Jugendmedizin
        • Contact:
        • Sub-Investigator:
          • Sabine Zeil, MD
        • Principal Investigator:
          • Christian Vogelberg, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Medical diagnosis of ≥3 episodes of wheezy bronchitis within the pre-vious 12 months
  2. Children aged from 1 to 3 years (girls and boys)
  3. Signed Informed Consent of the legal guardians to participate in the trial after written and verbal briefing by the Investigator
  4. No allergic sensitization
  5. Allowance to contact the familys pediatrician for medical history of wheezy bronchitis episodes

Exclusion Criteria:

  1. Anamnestically known intolerance/allergy to one of the drugs applied or to their ingredients or to drugs of similar chemical structure
  2. Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial
  3. Evidence suggesting that the patient or their legal representative is not likely to follow the trial protocol (e.g. lacking compliance)
  4. Inability to document the symptoms in a symptom log book or ques-tionnaire; inability to take the trial medication properly
  5. Any regular therapy except Vitamin D or Fluoride
  6. Chronic illnesses of different aetiology
  7. Premature birth or diagnosis of bronchopulmonary dysplasia
  8. Gastro-oesophageal reflux
  9. Hereditary fructose intolerance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Syrup
Placebo Syrup 2.5 ml twice daily for 4 weeks
Active Comparator: Prospan Syrup
Prospan Syrup 2.5 ml twice daily for 4 weeks
Drug: Prospan Syrup
2.5 ml twice daily for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the time to event (next bronchitis episode) rate during and after treatment period
Time Frame: three months
three months

Secondary Outcome Measures

Outcome Measure
Time Frame
days and percentage of days without bronchitis during and after treatment period
Time Frame: 3 months
3 months
days and percentage of days without bronchitis during treatment period
Time Frame: three months
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Investigators

  • Principal Investigator: Christian Vogelberg, MD PhD, Technische Universität Dresden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

January 13, 2014

First Submitted That Met QC Criteria

January 23, 2014

First Posted (Estimate)

January 27, 2014

Study Record Updates

Last Update Posted (Estimate)

January 27, 2014

Last Update Submitted That Met QC Criteria

January 23, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HeHe02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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