bronchial asthma is a very common medical problem in 3-7 year old children, often requiring hospitalization and demanding treatment on demand or permanently. Our trial is to compare to established treatment regimens with regard to their clinical efficacy
Conditions
Interventions
Trade Name: Singulair mini 4mg Kautablette
Product Name: Singulair
Pharmaceutical Form: Chewable tablet
INN or Proposed INN: Montelukast
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
Johann Wolfgang Goethe-Universität Frankfurt am Main
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: diagnosis of moderate bronchial asthma (GINA level I-II) in last 12 months usage of Beta-2-Agonists 4 weeks without exacerbations before Visite 1 written informed consent of parents / guardians Are the trial subjects under 18? yes Number of subjects for this age range: 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: chronic persisting asthma with regular inhalative steroid and/or Montelukast therapy patients age 7 years missing cooperation in the performance of lung function exazerbation within 28 days before visite 1 other severe disease conditions (e.g., cystic fibrosis, psychiatric disorders, neoplasms or history of immunosuppression) participation in other clinical trials < 30 days before the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Explorative comparison of Montelukast (4mg/5mg) with inhalative steroids (Fluticason 2 x 100 µg) to estimate responder profiles in preschool children suffering from bronchial asthma. main objective is the number of responders with very good asthma symptom control defined as requiring no rapid acting beta agonists (RABA) between the 2. and 6th week of intervention (end of trial). ;Secondary Objective: - number of patients requiring at least five times RABA between the 2. and 6th week of intervention (end of trial) - increase of forced expiratory volume in one second (FEV1) by 7.5% - clinical symptom score - number of patients requiring systemic corticosteroids - exhaled nitric oxide (eNO) as marker of bronchial inflammation - bronchial hyperreactivity determined by metacholine testing (PD20) - laboratory values: Leukotrien-levels in saliva, specific IgE (RAST>2) ;Primary end point(s): Primary efficacy endpoint: The primary efficacy variable is the number of responders with very good asthma symptom control defined as requiring no rapid acting beta agonist (RABA) between the 2. and 6th week of intervention (end of trial) | — |
Countries
Germany
Outcome results
None listed