UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of house dust mite sublingual immunotherapy in preschool children with allergic rhinitis
Acronym	Efficacy and safety of house dust mite sublingual immunotherapy in preschool children with allergic rhinitis
Scientific Title	Efficacy and safety of house dust mite sublingual immunotherapy in preschool children with allergic rhinitis
Scientific Title:Acronym	Efficacy and safety of house dust mite sublingual immunotherapy in preschool children with allergic rhinitis
Region	Japan

Condition
Condition	Perennial allergic rhinitis
Classification by specialty	Pediatrics Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the efficacy and safety of house dust mite sublingual immunotherapy for perennial allergic rhinitis in preschool children
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement rate of nasal and eye symptom scores after a year
Key secondary outcomes	Improvement rate of Medication scores after a year Frequency of adverse reaction Change of parameters in blood Sensitization of other inhaled antigens

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	4 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Patient with allergic rhinitis, who have specific IgE RAST score 1 for Dermatophagoides pteronyssinus. 2)Patient who have perennial allergic rhinitis symptoms.
Key exclusion criteria	1) Patients who have received immunotherapy. 2) Uncontrolled asthma patients. 3) Patients who were judged to be unsuitable for patient enrollment by their doctor.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Motohiro Middle name Last name Ebisawa
Organization	National Sagamihara Hospital
Division name	Department of Allergy, Clinical Research Center for Allergology and Rheumatology
Zip code	252-0392
Address	18-1, Sakuradai, Minami-ku, Sagamihara, Kanagawa , Japan
TEL	042-742-8311
Email	mebisawa@foodallergy.jp

Public contact
Name of contact person	1st name Koki Middle name Last name Sasamoto
Organization	National Sagamihara Hospital
Division name	Pediatrics
Zip code	252-0392
Address	18-1, Sakuradai, Minami-ku, Sagamihara, Kanagawa, Japan
TEL	042-742-8311
Homepage URL
Email	kohki_sasamoto_0131@yahoo.co.jp

Sponsor
Institute	National Sagamihara Hospital
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Hospital Organization Sagamihara National Hospital
Address	18-1, Sakuradai, Minami-ku, Sagamihara, Kanagawa 252-0392, Japan
Tel	042-742-8311
Email	222-rinri@mail.hosp.go.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 03 Month 25 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	38
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	No longer recruiting
Date of protocol fixation	2020 Year 02 Month 18 Day
Date of IRB	2020 Year 02 Month 18 Day
Anticipated trial start date	2020 Year 03 Month 25 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Changes in nasal symptoms by sublingual immunotherapy and investigation of adverse reactions by diary

Management information
Registered date	2020 Year 03 Month 25 Day
Last modified on	2021 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045538