asthma bronchiale in childhood
Conditions
Interventions
Trade Name: SINGULAIR junior° 5 mg
Product Name: singulair junior 5 mg
Pharmaceutical Form: Chewable tablet
INN or Proposed INN: Montelukast
Concentration unit: mg/g milligram(s)/gram
Concentration t
Sponsors
Research Institute for the prevention of allergy and airway diseases in childhood
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·Children and adolescents with symptomatic bronchial asthma despite ongoing therapy ·Age 6-14 years ·Asthma diagnosed at lease six months previously (by a special pulmonary allergologic outpatient unit) ·Demonstration of reversibility (FEV1 increased by at least 12% after bronchospasmolysis with a beta2 sympathomimetic). This can be determined at the screening visit or within the previous three months. ·Patients who are either steroid-naive or who received constant doses of the following medications within the previous four weeks: - Beclomethasone dipropionate: up to 400 µg daily - Fluticasone propionate: up to 200 µg daily - Budesonide: up to 400 µg daily · Patients who are able to reliably complete the asthma diary and perform peak flow measurements according to instructions. 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: ·Patients who were treated with systemic steroids within the previous 30 days ·Patients using one of the following asthma medications: Systemic steroids Nedocromil, DNCG Theophylline Ketotifen Systemic or long-acting beta2 sympathomimetics ·Patients who have experienced one of the following events within the previous 30 days: A change in asthma medication Pulmonary infection Hospitalization due to bronchial asthma or any other respiratory condition ·Patients who are currently participating in another clinical trial or have done so within the previous 30 days. ·Patients known or expected to react hypersensitively to components of the investigational medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main aim of the study is to develop a method that allows responders to be distinguished from non-responders before long-term treatment is initiated. ;Secondary Objective: Subsidiary aims are to record changes in pulmonary functional parameters, NO concentrations and peak flow variability, the use of beta2 sympathomimetics and the asthma symptom score.;Primary end point(s): The primary outcome variable is the proportion of patients whose FEV1 increases by 5% after administration of montelukast at Visit 2 in the non-responder and responder groups. | — |
Countries
Germany
Outcome results
None listed