UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for making diagnosis criteria of pediatric allergis rhinitis
Title of the study (Brief title)	Study of pediatric allergic rhintis
Region	Japan

Condition
Condition	Allergic rhinitis
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the necessary items to diagnosis pediatric allergic rhinitis
Basic objectives2	Others
Basic objectives -Others	To examine the item which is not necessary for a diagnosis of pediatric allergic rhinitis.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the necessary items to diagnosis pediatric allergic rhinitis
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	1 years-old <=
Age-upper limit	12 years-old >=
Gender	Male and Female
Key inclusion criteria	Children who consulted otolaryngology for nasal symptoms
Key exclusion criteria	Chilren who do not complain of nasal symptoms
Target sample size	1000

Research contact person
Name of lead principal investigator	Yoshitaka Okamoto
Organization	Chiba University Graduate School
Division name	Department of Otorhinolaryngology
Address	1-8-1 Inohana,Chuo-ku Chiba 260-8677
TEL	043-226-2137
Email	jibika@office.chiba-u.jp

Public contact
Name of contact person	Syuji Yonekura
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Otolaryngology
Address	1-8-1 Inohana,Chuo-ku, Chiba, 260-8677
TEL	043-226-2137
Homepage URL
Email	jibika@office.chiba-u.jp

Sponsor
Institute	Dept. of Otolaryngology, Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2015 Year 09 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 30 Day
Anticipated trial start date	2014 Year 11 Month 01 Day
Last follow-up date
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	Subjecs are pediatric patients (<13 yr old) with rhinitis who consulted otolaryngologist in Chiba univ., Yamagata univ., Nippon medical school, Saitama medical school, Yamanasi univ., Nagoya municipal univ., Mie univ., Fukui univ., Okayama univ. and their associated institutions after November 2014. The survey is conducted using a questionnarie. Investigation items are symptoms, nasal findings, IgE and eosinophils in nasal smear, etc.

Management information
Registered date	2015 Year 09 Month 09 Day
Last modified on	2018 Year 07 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021939