UMIN-CTR Clinical Trial

Basic information
Public title	Biomarker-based treatment option for preschool children with recurrent wheeze
Acronym	Biomarker-based treatment for preschool wheeze
Scientific Title	Biomarker-based treatment option for preschool children with recurrent wheeze
Scientific Title:Acronym	Biomarker-based treatment for preschool wheeze
Region	Japan

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

Objectives
Narrative objectives1	Compare effects of budesonide and montelukast for wheezing preschool children with specific biomarkers (elevated serum EDN and positive specific IgE to house dust mite
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Asthma Control Days
Key secondary outcomes	asthma exacerbation

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	budesonide inhalation suspension
Interventions/Control_2	montelukast
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	1 years-old <=
Age-upper limit	5 years-old >=
Gender	Male and Female
Key inclusion criteria	Recurrent wheeze more than 3 occasions (one should be confirmed by a physician) Improvement of wheeze by inhaled/oral short-acting beta2 agonisit Wheezing episodes within 2 weeks before enrollment Wheezing episodes during run-in period Positive specific IgE to house dust mite Serum EDN>53ng/ml
Key exclusion criteria	patients who have been treated with any asthma controller before enrollment
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takao Fujisawa
Organization	Mie National Hospital
Division name	Institute for Clinical Research
Zip code
Address	357 Osato-kubota, Tsu, Mie, Japan
TEL	059-232-2531
Email

Public contact
Name of contact person	1st name Middle name Last name Mizuho Nagao
Organization	Mie National Hospital
Division name	Institute for Clinical Research
Zip code
Address	357 Osato-kubota, Tsu, Mie, Japan
TEL	059-232-2531
Homepage URL
Email	mizuhonagao@mie-m.hosp.go.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	Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	いのうえ小児科・アレルギー科クリニック（岐阜県） ニコニコこどもクリニック（愛知県） 国立病院機構長良医療センター（岐阜県） 名古屋市立西部医療センター（愛知県） 大阪府立呼吸器・アレルギーセンター（大阪府） 名古屋第二赤十字病院（愛知県） 揖斐厚生病院（岐阜県） 郡上市民病院（岐阜県） しばた小児科医院（三重県） 大阪赤十字病院（大阪府） てらだアレルギーこどもクリニック（愛知県） 道雄会和田クリニック（愛知県） 徳田ファミリークリニック（三重県） 岐阜県立多治見病院（岐阜県） 三重県立総合医療センター（三重県） 大垣市民病院（岐阜県） クリニックちあき（愛知県）　　　　　　　　 土岐市立総合病院（岐阜県） 国立病院機構三重病院（三重県）

Other administrative information
Date of disclosure of the study information	2012 Year 07 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 02 Month 12 Day
Date of IRB	2012 Year 03 Month 15 Day
Anticipated trial start date	2012 Year 07 Month 01 Day
Last follow-up date	2014 Year 06 Month 01 Day
Date of closure to data entry	2014 Year 08 Month 01 Day
Date trial data considered complete	2014 Year 09 Month 01 Day
Date analysis concluded	2014 Year 11 Month 01 Day

Other
Other related information	Kim CK, Callaway Z, Park JS, Nishimori H, Ogino T, Nagao M, Fujisawa T. Montelukast Reduces Serum Levels of Eosinophil-Derived Neurotoxin in Preschool Asthma. Allergy, asthma & immunology research 2018; 10: 686-697.

Management information
Registered date	2012 Year 07 Month 03 Day
Last modified on	2020 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009812