Evaluation of efficacy of budesonide inhalation suspension for infants with severe intermittent asthma - A multicenter, open, randomized, parallel-group study -

INTERVENTION: Budesonide inhalation suspension (BIS): 0.5mg, once daily (If the asthma symptom is well‐controlled for the first 12 weeks, the dosage is titrated to 0.25mg once daily is admitted at 12 weeks.) Procaterol hydrochloride hydrate: 30 microg, as relief medication Procaterol hydrochloride hydrate: 30 microg, as relief medication CONDITION: bronchial asthma PRIMARY OUTCOME: Time to first severe exacerbation SECONDARY OUTCOME: Number of urgent visits to the medical institutions due to severe exacerbations of asthma; Total score of the questionnaires regarding asthma control; Score of each questionnaire regarding asthma control INCLUSION CRITERIA: 1)Infants whose age are from 6 months to less than 5 years 2)Infants diagnosed as asthma by standard of JPGL (repeated wheezing three times or more) 3)Infants hospitalized due to first severe exacerbation 4)Infants with intermittent or mild persistent asthma (without using long‐term control medicines) before severe exacerbation 5) Infants able to undergo continuous follow‐up treatment 6) Infants who normally grow (the height and the weight when agreement is acquired are within 3‐97 percentile of the infant body growth investigation report in 2000) 7) Infants whose parents provide written informed consent