UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008335 |
|---|---|
| Receipt number | R000009812 |
| Scientific Title | Biomarker-based treatment option for preschool children with recurrent wheeze |
| Date of disclosure of the study information | 2012/07/03 |
| Last modified on | 2020/05/22 09:27:40 |
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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
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
mizuhonagao@mie-m.hosp.go.jp
Sponsor or person
Institute
Mie National Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009812
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
