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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Technische Universität Dresden
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01692041
First received: May 3, 2012
Last updated: September 24, 2012
Last verified: September 2012
  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:


Further study details as provided by Technische Universität Dresden:

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:

  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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Technische Universität Dresden
  More Information

No publications provided

Responsible Party: Technische Universität Dresden
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 Technische Universität Dresden:
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 July 24, 2014