Clinical trial NCT01692041: Effect of an add-on Treatment With Ivy Leaves Dry Extract on Lung Function in Bronchial Asthma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Asthma
Keywords: asthma
children
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2012-09-25
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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 -

Primary outcomes:
measure: MEF75-25 before bronchodilation - relative change
timeFrame: every 4 weeks
measure: FEV1 before bronchodilation - relative change
timeFrame: every 4 weeks
Secondary outcomes:
measure: MEF75-25 before bronchodilation - absolute change
timeFrame: every 4 weeks
measure: FEV1 before bronchodilation - absolute change
timeFrame: every 4 weeks
measure: Emergency treatment (beta agonist demand)
timeFrame: daily
measure: Number of days with asthma symptoms
timeFrame: daily
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus, Kinderklinik
state: Saxonia
Study officials:
References: