Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma (LOS)
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Explorative comparison of montelukast with inhaled steroids (fluticasone) to estimate responder profiles, in terms of symptom scores, rescue medication, increase of FEV1, in correlation to presence of allergy, bronchial hyperreactivity (PD20), exhaled NO, excretion of leukotrienes, response to RABA and laboratory parameters in patients with pre-school asthma i.e. asthma phenotypes.
The primary efficacy variable is the number of responders with a 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)
Secondary Outcome Measures :
the number of patients requiring at least five times RABA between the 2. and 6th week, the number of patients with an increase of FEV1 7.5%, the symptom score, symptom free days, rescue medication, presence of allergy RAST > 2, concentration of eNO, PD20
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Ages Eligible for Study:
4 Years to 6 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female patients age 4 -6 years
Diagnosis of mild intermittent bronchial asthma (Step I-II) in the past 6 - 12 months as stated by the investigator:
Use of inhaled beta-2-agonists < 1/week (max 3 puff /d)
Exacerbation-free interval > 4 weeks prior to visit 1
The written informed consent of parents after received written and oral information about the aim, purpose and risks of the study must be present