UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of efficacy of budesonide inhalation suspension for infants with severe intermittent asthma - A multicenter, open, randomized, parallel-group study -
Title of the study (Brief title)	Evaluation of efficacy of budesonide inhalation suspension for infants with severe intermittent asthma
Region	Japan

Condition
Condition	bronchial asthma
Classification by specialty	Pneumology Clinical immunology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of inhaled corticosteroid (ICS) on infants with severe intermittent asthma by comparing two groups. One of the groups is treated by using ICS concomitant with short acting beta2 agonist (SABA) as needed, and the other is treated by using only SABA as needed.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time to first severe exacerbation
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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
Interventions/Control_2	Procaterol hydrochloride hydrate: 30 microg, as relief medication
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	6 months-old <=
Age-upper limit	60 months-old >
Gender	Male and Female
Key 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
Key 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
Target sample size	80

Research contact person
Name of lead principal investigator	Takao Fujisawa
Organization	Mie National Hospital
Division name	Institute for Clinical Research
Address	357 Osato-kubota, Tsu-shi, Mie, Japan
TEL	059-232-2531
Email	arai@mcp.co.jp

Public contact
Name of contact person	Kazuo Hirono
Organization	MC&P Co., Ltd.
Division name	Medical Sciences Marketing Division
Address	2-2-2 Nakanoshima, Kita-ku, Osaka, Japan
TEL	06-4716-3315
Homepage URL
Email	arai@mcp.co.jp

Sponsor
Institute	Mie National Hospital
Institute
Department

Funding Source
Organization	Japan Allergy Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2008 Year 12 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 09 Month 11 Day
Anticipated trial start date	2008 Year 10 Month 01 Day
Last follow-up date	2010 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2008 Year 12 Month 08 Day
Last modified on	2017 Year 06 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001880