EUCTR2011-003894-27-DEActive, not recruitingNot Applicable
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
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 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
- •F.1.3.1 Number of subjects for this age range
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 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
- •11.Pregnant or breastfeeding women
Investigators
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