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

Asthma Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01692041
• Other study ID #: HeHe
• Status: Recruiting
• Phase: Phase 2
• First received: May 3, 2012
• Last updated: September 24, 2012
• Start date: April 2012
• Est. completion date: December 2013

Study information

• Verified date: September 2012
• Source: Technische Universität Dresden
• Contact: Christian Vogelberg, MD PhD
• Phone: 0049 351 458 2073
• Email: christian.vogelberg[@]uniklinikum-dresden.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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 -

Study Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• ivy leaves dry extract
5 ml twice daily po
• Placebo
5 ml per os twice daily

Locations

Country	Name	City	State
Germany	Universitätsklinikum Carl Gustav Carus, Kinderklinik	Dresden	Saxonia

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	FEV1 before bronchodilation - relative change	FEV1 before bronchodilation will be measured at every study visit and changes will be documented	every 4 weeks	No
Secondary	MEF75-25 before bronchodilation - absolute change		every 4 weeks	No
Secondary	FEV1 before bronchodilation - absolute change	FEV1 before bronchodilation will be measured every visit and changes documented	every 4 weeks	No
Secondary	Emergency treatment (beta agonist demand)	Emergency treatment (beta agonist demand)will be documented daily at home and checked at every study visit	daily	Yes
Secondary	Number of days with asthma symptoms	Number of days with asthma symptoms will be documented daily and checked at every study visit.	daily	Yes