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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040007
Receipt No. R000045586
Scientific Title Persistence and adherence to HDM SLIT in Japanese children with allergic rhinitis: A multicenter, prospective, observational study.
Date of disclosure of the study information 2020/04/01
Last modified on 2020/05/07

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Basic information
Public title Persistence and adherence to HDM SLIT in Japanese children with allergic rhinitis: A multicenter, prospective, observational study.
Acronym Persistence and adherence to HDM SLIT in Japanese children.
Scientific Title Persistence and adherence to HDM SLIT in Japanese children with allergic rhinitis: A multicenter, prospective, observational study.
Scientific Title:Acronym Persistence and adherence to HDM SLIT in Japanese children.
Region
Japan

Condition
Condition Allergic rhinitis
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal the persistence and adherence rate of HDM SLIT among Japanese children with allergic rhinitis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Persistence rate of HDM SLIT.
Key secondary outcomes 1: Factors associated with HDM SLIT persistence.
2: Factors associated with clinical effects.
3: Sensitization status at the start of HDM SLIT.
4: Factors associated with changes in sensitization status after HDM SLIT.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
5 years-old <=
Age-upper limit
13 years-old >
Gender Male and Female
Key inclusion criteria Children aged 5 to 12 years old who start HDM SLIT with Miticure for allergic rhinitis from April 2020 to March 2022.
Key exclusion criteria 1: Patients who have received dust mite immunotherapy.
2: Patients receiving biologic therapy at the start of Miticure administration.
3: Patients who have been receiving systemic steroids for more than 28 days at the start of Miticure administration.
4: Patients considered ineligible by the principal investigator.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Yoshida
Organization Tokyo Metropolitan Children's Medical Center
Division name Department of Allergy
Zip code 183-8561
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
TEL 0423005111
Email kouichi_yoshida@tmhp.jp

Public contact
Name of contact person
1st name Ayako
Middle name
Last name Nigo
Organization Tokyo Metropolitan Children's Medical Center
Division name Department of General Pediatrics
Zip code 183-8561
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
TEL 0423005111
Homepage URL
Email ayako_nigo@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization Japanese Society of Pediatric Allergy and Clinical Immunology

Torii Pharmaceutical Co., LTD.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tokyo Metropolitan Children's Medical Center
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
Tel 0423005111
Email sn_rinri@tmhp.jp

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
2020 Year 04 Month 01 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 Open public recruiting
Date of protocol fixation
2020 Year 03 Month 19 Day
Date of IRB
2020 Year 03 Month 19 Day
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2027 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2020 Year 03 Month 31 Day
Last modified on
2020 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045586

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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