bronchial asthma
Conditions
Interventions
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.)
Sponsors
Mie National Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1)Infants of less than 2500 grams in weight at the birth 2)Infants who have chronic ailment in lungs, heart, kidney, liver, and blood, etc. 3)Infants to whom long-term control asthma medicine were administered (however, the case who were administered anti-leukotriene medicines within one week three months ago is not excluded) 4)Infants who have previous history of adrenal cortical insufficiency or accentuation syndrome 5)Infants who have received systemic steroid in the past (however, the case who were administered it for the diseases other than asthma (croup syndrome etc.) before three months or more is not excluded) 6)Infants who were taking steroid medicines continuously within six months in the past (including point bribes, not including medicines for external application) 7)Infants who required two weeks or more for the acute treatment 8)Infants who have previous history of hypersensitivity for treatment 9)Infants of hospitalization by bacterial pneumonia or RSV minute bronchitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first severe exacerbation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactKazuo Hirono
MC&P Co., Ltd. Medical Sciences Marketing Division
Outcome results
None listed