Suspended

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

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What is being tested

ivy leaves dry extract

+ Placebo

Drug
Who is being recruted

Bronchial Diseases+6

+ Hypersensitivity

+ Hypersensitivity, Immediate

From 6 to 12 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: April 2012
See protocol details

Summary

Principal SponsorTechnische Universität Dresden
Study ContactChristian Vogelberg, MD PhDMore contacts
Last updated: September 25, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01692041
Principal SponsorTechnische Universität Dresden
Study ContactChristian Vogelberg, MD PhDMore contacts
Last updated: September 25, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 to 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLung DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityRespiratory Tract DiseasesAsthma

Criteria

5 inclusion criteria required to participate
Asthma diagnosis for at least 1 year
Children aged from 6 to 12 years (girls and boys)
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
Medical diagnosis of uncontrolled, mild, persistent, allergic bronchial asthma in terms of the bronchial asthma NVL Version 1.3 (2011)
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11 exclusion criteria prevent from participating
Acute respiratory infection within the previous 4 weeks
Anamnestically known intolerance/allergy to one of the drugs applied or to their ingredients or to drugs of similar chemical structure
Chronic illnesses of different aetiology
Evidence suggesting that the patient or their legal representative is not likely to follow the trial protocol (e.g. lacking compliance)
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Universitätsklinikum Carl Gustav Carus, Kinderklinik

Dresden, GermanyOpen Universitätsklinikum Carl Gustav Carus, Kinderklinik in Google Maps
SuspendedOne Study Center