UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the relationship between biomarkers in nasal discharge during initial wheezing and the onset of asthma in early childhood
Acronym	Examination of the relationship between biomarkers in nasal discharge during initial wheezing and the onset of asthma in early childhood
Scientific Title	Examination of the relationship between biomarkers in nasal discharge during initial wheezing and the onset of asthma in early childhood
Scientific Title:Acronym	Examination of the relationship between biomarkers in nasal discharge during initial wheezing and the onset of asthma in early childhood
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to clarify biomarkers that predict the onset of recurrent wheezing and asthma using blood and nasal discharge obtained under normal medical care for children who first wheeze in infancy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Differences in nasal discharge biomarkers tested at the time of screening between children in the IgE-related asthma group, non-IgE-related asthma group, and non-asthma group.
Key secondary outcomes

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	Not applicable
Age-upper limit	2 years-old >
Gender	Male and Female
Key inclusion criteria	Infants under 2 years old who were hospitalized for lower respiratory tract infection and wheezing for the first time after birth Children who have consented to participate in this study from their substitutes
Key exclusion criteria	Preterm infants (less than 37 weeks) Children who required respiratory management during the newborn period, children with chronic lung disease Children with a history of autoimmune diseases or metabolic diseases Children who received treatment by steroids (inhalation, nasal drops, systemic administration) before sample collection (within 24 hours) Other children who the researcher deems inappropriate for participating in this study
Target sample size	148

Research contact person
Name of lead principal investigator	1st name Fumitaka Middle name Last name Takayanagi
Organization	Dokkyo Medical University Hospital
Division name	Pediatrics
Zip code	321-0293
Address	880 Ozikiitakobayasshi Mibu Shimotsuga Tochigi
TEL	0282-86-1111
Email	fumi_fena@yahoo.co.jp

Public contact
Name of contact person	1st name Fumitaka Middle name Last name Takayanagi
Organization	Dokkyo Medical University Hospital
Division name	Pediatrics
Zip code	321-0293
Address	880 Ozikiitakobayasshi Mibu Shimotsuga Tochigi
TEL	0282-86-1111
Homepage URL
Email	fumi_fena@yahoo.co.jp

Sponsor
Institute	Dokkyo Medical University Hospital
Institute
Department

Funding Source
Organization	Dokkyo Medical University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Dokkyo Medical University Hospital
Address	880 Ozikiitakobayasshi Mibu Shimotsuga Tochigi
Tel	0282-86-1111
Email	fumi_fena@yahoo.co.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	2021 Year 06 Month 26 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	2021 Year 06 Month 01 Day
Date of IRB	2021 Year 06 Month 01 Day
Anticipated trial start date	2021 Year 06 Month 01 Day
Last follow-up date	2029 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This study is a multicenter prospective cohort study. We enroll all patients who visited our hospital between approval by the Clinical Research Ethics Committee in 2021 and March 2023 who met the selection criteria. We take a nasal discharge sample at admission and measure biomarkers. After that, a questionnaire survey will be conducted every year for 5 years to evaluate the onset of asthma. In addition, after 2 years and 5 years, asthma phenotypes will be classified according to the presence or absence of an increase in IgE, and it will be examined whether biomarkers differ for each phenotype.

Management information
Registered date	2021 Year 06 Month 25 Day
Last modified on	2021 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050723