Effect of an add-on Treatment With Ivy Leaves Dry Extract on Lung Function in Bronchial Asthma

Study Overview
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Brief Summary
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The trial aims to record possible effects of a supplementary treatment with ivy leaves dry extract on different lung function parameter, on bronchial hyperreactivity, on individual markers of asthmatic inflammation and on the clinical symptom profile. The hypothesis is, that the additional therapy might improve these parameters and might help to optimize asthma therapy.

Official Title
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Tolerance and Effect of an add-on Treatment With a Cough Medicine Containing Ivy Leaves Dry Extract on Lung Function in Children With Bronchial Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: ivy leaves dry extract
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical diagnosis of uncontrolled, mild, persistent, allergic bronchial asthma in terms of the bronchial asthma NVL Version 1.3 (2011) Children aged from 6 to 12 years (girls and boys) Signed Informed Consent of the patient and his legal guardians to participate in the trial after written and verbal briefing by the Investigator Improvement of the FEV1≥12% after 2 puffs of terbutaline 100 µg dur-ing steroid monotherapy with 400 µg budesonide equivalent/day or an ACT score ≤ 19 as an indication of insufficient asthma control Asthma diagnosis for at least 1 year 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 measure lung function, to test bronchospasmolysis, to determine FeNO or to collect exhaled breath condensate, inability to document the symptoms in a symptom log book or questionnaire; in-ability to take the trial medication properly Chronic illnesses of different aetiology Vocal cord dysfunction Premature birth or diagnosis of bronchopulmonary dysplasia Gastroesophageal reflux Acute respiratory infection within the previous 4 weeks Hereditary fructose intolerance Pregnant or breastfeeding girls -

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ivy leave<br>active therapy arm with Ivy leave 5 ml twice daily p.o. for four weeks | Drug: ivy leaves dry extract<br>* 5 ml twice daily po<br>|
| Placebo Comparator: Placebo<br>Ivy leave placebo 5 ml twice daily p.o. for four weeks | Drug: Placebo<br>* 5 ml per os twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MEF75-25 before bronchodilation - relative change | MEF75-25 will be measured at every time point of the study and relative changes will be followed | every 4 weeks | 
| FEV1 before bronchodilation - relative change | FEV1 before bronchodilation will be measured at every study visit and changes will be documented | every 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MEF75-25 before bronchodilation - absolute change |  | every 4 weeks | 
| FEV1 before bronchodilation - absolute change | FEV1 before bronchodilation will be measured every visit and changes documented | every 4 weeks | 
| Emergency treatment (beta agonist demand) | Emergency treatment (beta agonist demand)will be documented daily at home and checked at every study visit | daily | 
| Number of days with asthma symptoms | Number of days with asthma symptoms will be documented daily and checked at every study visit. | daily | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, children