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

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

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.

Study Overview

• Status: Unknown
• Conditions: Asthma
• Intervention / Treatment: Drug: ivy leaves dry extract; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Christian Vogelberg, MD PhD; Phone Number: 0049 351 458 2073; Email: christian.vogelberg@uniklinikum-dresden.de

Study Locations

• Germany
  • Saxonia
    • Dresden, Saxonia, Germany, 01307
      • Recruiting
      • Universitätsklinikum Carl Gustav Carus, Kinderklinik
      • Sub-Investigator: Sabine Zeil, MD
      • Principal Investigator: Christian Vogelberg, MD PhD
      • Contact: Christian Vogelberg, MD PhD; Phone Number: 2073 0049 351 458; Email: christian.vogelberg@uniklinikum-dresden.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Technische Universität Dresden

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: May 3, 2012
• First Submitted That Met QC Criteria: September 24, 2012
• First Posted (Estimate): September 25, 2012

Study Record Updates

• Last Update Posted (Estimate): September 25, 2012
• Last Update Submitted That Met QC Criteria: September 24, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: children; asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: HeHe