Pediatric patients age 6-12 yrs with uncontrolled mild persistent asthma MedDRA version: 14.1 Level: LLT Classification code 10003555 Term: Asthma bronchial System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Prospan Hustensaft
Product Name: Prospan Hustensaft
Product Code: Prospan Hustensaft
Pharmaceutical Form: Oral liquid
Other descriptive name: IVY LEAVES, DRY EXTRACT
Concentration unit: g/
Sponsors
Technische Universität Dresden
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of an additional therapy with Prospan on the lung function parameters MEF75-25 and FEV1 (relative change) ;Secondary Objective: To evaluate the effect of an additional therapy with Prospan on 1. MEF75-25 before bronchodilation – absolute change between V2 and V3, and between V4 and V5 respectively 2. FEV1 before bronchodilation – absolute change between V2 and V3, and between V4 and V5 respectively 3. FeNO 4. Exhaled breath condensate pH 5. Peak flow profile 6. Emergency treatment (beta agonist) 7. Number of days with asthma symptoms 8. ACT result 9. ACQ result 10. Tolerance ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. MEF75-25 before bronchodilation – absolute change between V2 and V3, and between V4 and V5 respectively 2. FEV1 before bronchodilation – absolute change between V2 and V3, and between V4 and V5 respectively 3. FeNO 4. Exhaled breath condensate pH 5. Peak flow profile 6. Emergency treatment (beta agonist) 7. Number of days with asthma symptoms 8. ACT result 9. ACQ result 10. Tolerance ;Timepoint(s) of evaluation of this end point: days-28, 0, 28, 56, 84, 112 | — |
Countries
Germany
Contacts
Public ContactPD Dr. Christian Vogelberg
Universitätsklinikum Carl Gustav Carus
Outcome results
None listed