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

Technische Universität Dresden

Status and phase: Unknown; Phase 2

Conditions: Asthma

Treatments: Drug: ivy leaves dry extract; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01692041

HeHe

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Ivy leave

Active Comparator group

Description:

active therapy arm with Ivy leave 5 ml twice daily p.o. for four weeks

Treatment:

Drug: ivy leaves dry extract

Placebo

Placebo Comparator group

Description:

Ivy leave placebo 5 ml twice daily p.o. for four weeks

Treatment:

Drug: Placebo