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

This study is currently recruiting participants.

Verified September 2012 by Dresden University of Technology

Sponsor:

Information provided by (Responsible Party):

Dresden University of Technology

ClinicalTrials.gov Identifier:

NCT01692041

First received: May 3, 2012

Last updated: September 24, 2012

Last verified: September 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: ivy leaves dry extract Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:

MEF75-25 before bronchodilation - relative change [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
MEF75-25 will be measured at every time point of the study and relative changes will be followed
FEV1 before bronchodilation - relative change [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
FEV1 before bronchodilation will be measured at every study visit and changes will be documented

Secondary Outcome Measures:

MEF75-25 before bronchodilation - absolute change [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
FEV1 before bronchodilation - absolute change [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
FEV1 before bronchodilation will be measured every visit and changes documented
Emergency treatment (beta agonist demand) [ Time Frame: daily ] [ Designated as safety issue: Yes ]
Emergency treatment (beta agonist demand)will be documented daily at home and checked at every study visit
Number of days with asthma symptoms [ Time Frame: daily ] [ Designated as safety issue: Yes ]
Number of days with asthma symptoms will be documented daily and checked at every study visit.

Estimated Enrollment:	30
Study Start Date:	April 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	6 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Medical diagnosis of uncontrolled, mild, persistent, allergic bronchial asthma in terms of the bronchial asthma NVL Version 1.3 (2011)
Children aged from 6 to 12 years (girls and boys)
Signed Informed Consent of the patient and his legal guardians to participate in the trial after written and verbal briefing by the Investigator
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
Asthma diagnosis for at least 1 year

Exclusion Criteria:

Anamnestically known intolerance/allergy to one of the drugs applied or to their ingredients or to drugs of similar chemical structure
Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial
Evidence suggesting that the patient or their legal representative is not likely to follow the trial protocol (e.g. lacking compliance)
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
Chronic illnesses of different aetiology
Vocal cord dysfunction
Premature birth or diagnosis of bronchopulmonary dysplasia
Gastroesophageal reflux
Acute respiratory infection within the previous 4 weeks
Hereditary fructose intolerance
Pregnant or breastfeeding girls -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692041

Contacts

Contact: Christian Vogelberg, MD PhD

0049 351 458 2073

christian.vogelberg@uniklinikum-dresden.de

Locations

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

Sponsors and Collaborators

Dresden University of Technology

More Information

No publications provided

Responsible Party:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT01692041 History of Changes
Other Study ID Numbers:	HeHe
Study First Received:	May 3, 2012
Last Updated:	September 24, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

asthma
children

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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