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

UMIN ID: UMIN000001557

Registered date:08/12/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: bronchial asthma
• Date of first enrollment: 2008/10/01
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• 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

Key inclusion & exclusion criteria

• Age minimum: 6months-old
• Age maximum: 60months-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Mie National Hospital
• Source(s) of Monetary Support: Japan Allergy Foundation