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

NCT ID: NCT01692041

Last Updated: 2012-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Asthma

Keywords

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asthma children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ivy leave

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

Group Type ACTIVE_COMPARATOR

ivy leaves dry extract

Intervention Type DRUG

5 ml twice daily po

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

5 ml per os twice daily

Interventions

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ivy leaves dry extract

5 ml twice daily po

Intervention Type DRUG

Placebo

5 ml per os twice daily

Intervention Type DRUG

Eligibility Criteria

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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 -
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitätsklinikum Carl Gustav Carus, Kinderklinik

Dresden, Saxony, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Christian Vogelberg, MD PhD

Role: CONTACT

Phone: 0049 351 458 2073

Email: [email protected]

Facility Contacts

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Christian Vogelberg, MD PhD

Role: primary

Other Identifiers

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HeHe

Identifier Type: -

Identifier Source: org_study_id