Tolerance and effect of an add-on therapy with an ivy leaves dry extract syrup on lung function in children with asthma. - Tolerance and effect of dried ivy leaf extract in bronchial asthma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pediatric patients age 6-12 yrs with uncontrolled mild persistent asthma
Sponsor: Technische Universität Dresden
Status: Active, not recruiting
Last Updated: 11 years ago

No summary available.

Registry

who.int

Start Date

February 15, 2012

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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 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 during steroid monother\-apy with 400 µg budesonide equivalent/day or an ACT score \= 19 as an indication of insuf\-ficient asthma control
•5\.Asthma diagnosis for at least one year
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 30
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no

•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 enroll\-ment in this trial
•3\.Patients or their legal representatives who are unable to understand the written and/or verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the trial (e.g. lacking compliance)
•4\.Inability to measure lung function, to test bronchospasmolysis, to determine FeNO or to col\-lect exhaled breath condensate, inability to document the symptoms in a symptom log book or questionnaire; inability 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\.Gastro\-oesophageal reflux
•9\.Acute respiratory infection within the previous 4 weeks
•10\.Hereditary fructose intolerance