Tolerance and effect of an add-on therapy with an ivy leaves dry extract syrup on lung function in children with asthma.
- Conditions
- Pediatric patients age 6-12 yrs with uncontrolled mild persistent asthmaMedDRA version: 14.1Level: LLTClassification code 10003555Term: Asthma bronchialSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2011-003894-27-DE
- Lead Sponsor
- Technische Universität Dresden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect of an additional therapy with Prospan on the lung function parameters MEF75-25 and FEV1 (relative change)<br>;Secondary Objective: To evaluate the effect of an additional therapy with Prospan on <br>1.MEF75-25 before bronchodilation – absolute change between V2 and V3, and between V4 and V5 respectively<br>2.FEV1 before bronchodilation – absolute change between V2 and V3, and between V4 and V5 respectively<br>3.FeNO<br>4.Exhaled breath condensate pH <br>5.Peak flow profile<br>6.Emergency treatment (beta agonist)<br>7.Number of days with asthma symptoms <br>8.ACT result<br>9.ACQ result <br>10.Tolerance<br><br><br>;Primary end point(s): Change of MEF75-25 and FEV1 ;Timepoint(s) of evaluation of this end point: days-28, 0, 28, 56, 84, 112
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1.MEF75-25 before bronchodilation – absolute change between V2 and V3, and between V4 and V5 respectively<br>2.FEV1 before bronchodilation – absolute change between V2 and V3, and between V4 and V5 respectively<br>3.FeNO<br>4.Exhaled breath condensate pH <br>5.Peak flow profile<br>6.Emergency treatment (beta agonist)<br>7.Number of days with asthma symptoms <br>8.ACT result<br>9.ACQ result <br>10.Tolerance<br><br>;Timepoint(s) of evaluation of this end point: days-28, 0, 28, 56, 84, 112