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

Phase 2

• Conditions: Asthma
• Interventions: Drug: ivy leaves dry extract; Drug: Placebo

• Registration Number: NCT01692041
• Lead Sponsor: Technische Universität Dresden

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-05-03
• Status Verified: 2012-09
• Study First Submitted QC: 2012-09-24
• Last Update Submitted: 2012-09-24
• Study First Posted: 2012-09-25
• Last Update Posted: 2012-09-25
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ivy leave	ivy leaves dry extract	active therapy arm with Ivy leave 5 ml twice daily p.o. for four weeks
Placebo	Placebo	Ivy leave placebo 5 ml twice daily p.o. for four weeks

Primary Outcome Measures

Name	Time	Method
MEF75-25 before bronchodilation - relative change	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	every 4 weeks	FEV1 before bronchodilation will be measured at every study visit and changes will be documented

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universitätsklinikum Carl Gustav Carus, Kinderklinik; 🇩🇪 Dresden, Saxonia, Germany