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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Wheezy Bronchitis, Recurrent Bronchitis

Intervention / Treatment
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* Drug: Prospan Syrup


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical diagnosis of ≥3 episodes of wheezy bronchitis within the pre-vious 12 months Children aged from 1 to 3 years (girls and boys) Signed Informed Consent of the legal guardians to participate in the trial after written and verbal briefing by the Investigator No allergic sensitization Allowance to contact the familys pediatrician for medical history of wheezy bronchitis episodes Exclusion Criteria: Anamnestically known intolerance/allergy to one of the drugs applied or to their ingredients or to drugs of similar chemical structure Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial Evidence suggesting that the patient or their legal representative is not likely to follow the trial protocol (e.g. lacking compliance) Inability to document the symptoms in a symptom log book or ques-tionnaire; inability to take the trial medication properly Any regular therapy except Vitamin D or Fluoride Chronic illnesses of different aetiology Premature birth or diagnosis of bronchopulmonary dysplasia Gastro-oesophageal reflux Hereditary fructose intolerance

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Syrup<br>Placebo Syrup 2.5 ml twice daily for 4 weeks | |
| Active Comparator: Prospan Syrup<br>Prospan Syrup 2.5 ml twice daily for 4 weeks | Drug: Prospan Syrup<br>* 2.5 ml twice daily for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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