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

NCT01692041 | Unknown Phase 2 DMC

• 1 other identifier: HeHe
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

asthma; children

Outcome Measures

Primary Outcomes (2)

• MEF75-25 before bronchodilation - relative change

  MEF75-25 will be measured at every time point of the study and relative changes will be followed

  every 4 weeks

• FEV1 before bronchodilation - relative change

  FEV1 before bronchodilation will be measured at every study visit and changes will be documented

  every 4 weeks

Secondary Outcomes (4)

• MEF75-25 before bronchodilation - absolute change

  every 4 weeks

• FEV1 before bronchodilation - absolute change

  every 4 weeks

• Emergency treatment (beta agonist demand)

  daily

• Number of days with asthma symptoms

  daily

Study Arms (2)

Ivy leave

ACTIVE COMPARATOR

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

Drug: ivy leaves dry extract

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

ivy leaves dry extract DRUG

5 ml twice daily po

Ivy leave

Placebo DRUG

5 ml per os twice daily

Placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

Universitätsklinikum Carl Gustav Carus, Kinderklinik

Dresden, Saxony, 01307, Germany

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

EA 575 extract

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Christian Vogelberg, MD PhD

CONTACT

0049 351 458 2073; christian.vogelberg@uniklinikum-dresden.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: September 25, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 25, 2012

Record last verified: 2012-09

Locations

DE (1)