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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: December 2013

Interventions

  • Drug: ivy leaves dry extract
    • 5 ml twice daily po
  • Drug: Placebo
    • 5 ml per os twice daily

Arms, Groups and Cohorts

  • Active Comparator: Ivy leave
    • active therapy arm with Ivy leave 5 ml twice daily p.o. for four weeks
  • Placebo Comparator: Placebo
    • Ivy leave placebo 5 ml twice daily p.o. for four weeks

Clinical Trial Outcome Measures

Primary Measures

  • MEF75-25 before bronchodilation – relative change
    • Time Frame: every 4 weeks
    • MEF75-25 will be measured at every time point of the study and relative changes will be followed
  • FEV1 before bronchodilation – relative change
    • Time Frame: every 4 weeks
    • FEV1 before bronchodilation will be measured at every study visit and changes will be documented

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

1. Medical diagnosis of uncontrolled, mild, persistent, allergic bronchial asthma in terms of the bronchial asthma NVL Version 1.3 (2011)

2. Children aged from 6 to 12 years (girls and boys)

3. Signed Informed Consent of the patient and his legal guardians to participate in the trial after written and verbal briefing by the Investigator

4. 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

5. Asthma diagnosis for at least 1 year

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 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

5. Chronic illnesses of different aetiology

6. Vocal cord dysfunction

7. Premature birth or diagnosis of bronchopulmonary dysplasia

8. Gastroesophageal reflux

9. Acute respiratory infection within the previous 4 weeks

10. Hereditary fructose intolerance

11. Pregnant or breastfeeding girls

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Technische Universität Dresden
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Christian Vogelberg, MD PhD, 0049 351 458 2073, christian.vogelberg@uniklinikum-dresden.de

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