NIPH Clinical Trials Search

UMIN ID: UMIN000001557

Registered date:08/12/2008

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedbronchial asthma
Date of first enrollment2008/10/01
Target sample size80
Countries of recruitmentJapan
Study typeInterventional
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


Primary OutcomeTime to first severe exacerbation
Secondary OutcomeNumber 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 minimum6months-old
Age maximum60months-old
GenderMale and Female
Include criteria
Exclude criteria1)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


public contact
Name Kazuo Hirono
Address 2-2-2 Nakanoshima, Kita-ku, Osaka, Japan Japan
Telephone 06-4716-3315
Affiliation MC&P Co., Ltd. Medical Sciences Marketing Division
scientific contact
Name Takao Fujisawa
Address 357 Osato-kubota, Tsu-shi, Mie, Japan Japan
Telephone 059-232-2531
Affiliation Mie National Hospital Institute for Clinical Research