Back to resultsEffect of an add-on Treatment With Ivy Leaves Dry Extract on Lung Function in Bronchial Asthma (HeHe)
Primary Purpose
Asthma
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
ivy leaves dry extract
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring asthma, children
Eligibility 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 -
Sites / Locations
- Universitätsklinikum Carl Gustav Carus, KinderklinikRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ivy leave
Placebo
Arm Description
active therapy arm with Ivy leave 5 ml twice daily p.o. for four weeks
Ivy leave placebo 5 ml twice daily p.o. for four weeks
Outcomes
Primary Outcome Measures
MEF75-25 before bronchodilation - relative change
MEF75-25 will be measured at every time point of the study and relative changes will be followed
FEV1 before bronchodilation - relative change
FEV1 before bronchodilation will be measured at every study visit and changes will be documented
Secondary Outcome Measures
MEF75-25 before bronchodilation - absolute change
FEV1 before bronchodilation - absolute change
FEV1 before bronchodilation will be measured every visit and changes documented
Emergency treatment (beta agonist demand)
Emergency treatment (beta agonist demand)will be documented daily at home and checked at every study visit
Number of days with asthma symptoms
Number of days with asthma symptoms will be documented daily and checked at every study visit.
Full Information
NCT ID
NCT01692041
First Posted
May 3, 2012
Last Updated
September 24, 2012
Sponsor
Technische Universität Dresden
1. Study Identification
Unique Protocol Identification Number
NCT01692041
Brief Title
Effect of an add-on Treatment With Ivy Leaves Dry Extract on Lung Function in Bronchial Asthma
Acronym
HeHe
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ivy leave
Arm Type
Active Comparator
Arm Description
active therapy arm with Ivy leave 5 ml twice daily p.o. for four weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Ivy leave placebo 5 ml twice daily p.o. for four weeks
Intervention Type
Drug
Intervention Name(s)
ivy leaves dry extract
Intervention Description
5 ml twice daily po
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
5 ml per os twice daily
Primary Outcome Measure Information:
Title
MEF75-25 before bronchodilation - relative change
Description
MEF75-25 will be measured at every time point of the study and relative changes will be followed
Time Frame
every 4 weeks
Title
FEV1 before bronchodilation - relative change
Description
FEV1 before bronchodilation will be measured at every study visit and changes will be documented
Time Frame
every 4 weeks
Secondary Outcome Measure Information:
Title
MEF75-25 before bronchodilation - absolute change
Time Frame
every 4 weeks
Title
FEV1 before bronchodilation - absolute change
Description
FEV1 before bronchodilation will be measured every visit and changes documented
Time Frame
every 4 weeks
Title
Emergency treatment (beta agonist demand)
Description
Emergency treatment (beta agonist demand)will be documented daily at home and checked at every study visit
Time Frame
daily
Title
Number of days with asthma symptoms
Description
Number of days with asthma symptoms will be documented daily and checked at every study visit.
Time Frame
daily
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Vogelberg, MD PhD
Phone
0049 351 458 2073
Email
christian.vogelberg@uniklinikum-dresden.de
Facility Information:
Facility Name
Universitätsklinikum Carl Gustav Carus, Kinderklinik
City
Dresden
State/Province
Saxonia
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Vogelberg, MD PhD
Phone
0049 351 458
Ext
2073
Email
christian.vogelberg@uniklinikum-dresden.de
First Name & Middle Initial & Last Name & Degree
Christian Vogelberg, MD PhD
First Name & Middle Initial & Last Name & Degree
Sabine Zeil, MD
12. IPD Sharing Statement
Learn more about this trial
Effect of an add-on Treatment With Ivy Leaves Dry Extract on Lung Function in Bronchial Asthma
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