Bronchial asthma
Conditions
Interventions
Montelukast + on demand use of beta2 agonists
on demand use of beta2 agonists
Sponsors
Le-PAT study group
The Waksman Foundation of Japan, INC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: children with asthma symptoms more than once a month and less than once a week, which is graded as mild persistent in JPGL. 2-5 years old: diagnosis of asthma is based on JPGL. 1 years old: category A + one of category B Category A: improvement of wheezing, dyspnea, or oxygen saturation after inhalation of a short-acting beta2 agonist Category B: 1 physician-diagnosed atopic dermatitis, 2 physician-diagnosed food allergy, 3 physician-diagnosed parental asthma
Exclusion criteria
Exclusion criteria: 1 use of anti-allergics within 6 months before enrollment (cromolyns, anti-histamines, suplatast, montelukast, pranlukast) 2 use of inhaled and systemic corticosteroids within 6 months before enrollment 3 use of theophylline within 6 months before enrollment 4 hypersensitivity to montelukast 5 use of long-acting beta2 agonists within 6 months before enrollment (permit short-term use of tuloburol patch) 6 conditions that a responsible investigator judges inapproriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of asthma exacerbation episodes | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Time to first asthma exacerbation 2) Time to loss of asthma control that needs inhaled corticosteroids 3) Symptom-free days | — |
Countries
Japan
Contacts
Public ContactMizuho Nagao
Mie National Hospital Institute for Clinical Research
Outcome results
None listed