UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and Safety of Sequential Sublingual Immunotherapy with Japanese Ceder Pollen and House Dust Mite allergens
Acronym	Efficacy and Safety of Sequential SLIT with JCP and HDM
Scientific Title	Efficacy and Safety of Sequential Sublingual Immunotherapy with Japanese Ceder Pollen and House Dust Mite allergens
Scientific Title:Acronym	Efficacy and Safety of Sequential SLIT with JCP and HDM
Region	Japan

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

Objectives
Narrative objectives1	Examination of efficacy and safety of sequential Sublingual Immunotherapy with Japanese Ceder Pollen and House Dust Mite allergens
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Examination of side effects:Evaluate about the presence of local reaction and systemic reaction at the medical examination.
Key secondary outcomes	Examination of efficacy:symptom-medication score, QOL, VAS scale

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Japanese ceder pollen and house dust mite allergic rhinitis
Key exclusion criteria	Patients who can not obtain written research cooperation. Patients who can not confirm their own consent to participate in research. Patients who are judged not to participate in this study by their doctor
Target sample size	184

Research contact person
Last name of lead principal investigator	1st name Hideaki Middle name Last name Kohzaki
Organization	Shiga University of Medical Science
Division name	otorhinolaryngology
Zip code	520-2192
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL	0775482111
Email	hkohzaki@belle.shiga-med.ac.jp

Public contact
1st name of contact person	1st name Hideaki Middle name Last name Kohzaki
Organization	Shiga University of Medical Science
Division name	otorhinolaryngology
Zip code	520-2192
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL	0775482111
Homepage URL
Email	hkohzaki@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Shiga University of Medical Science
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	Shiga University of Medical Science
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
Tel	0775482111
Email	hkohzaki@belle.shiga-med.ac.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	2019 Year 04 Month 11 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	2018 Year 03 Month 19 Day
Date of IRB	2018 Year 03 Month 30 Day
Anticipated trial start date	2018 Year 03 Month 30 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Evaluate the efficacy and safety of sequential sublingual immunotherapy with Japanese Ceder Pollen and House Dust Mite allergens as compared with single sublingual immunotherapy with Japanese Ceder Pollen or House Dust Mite.

Management information
Registered date	2019 Year 04 Month 10 Day
Last modified on	2019 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041484