UMIN-CTR Clinical Trial

Basic information
Public title	Immunological effects of sublingual immunotherapy with Japanese cedar pollen extract in patients with combined Japanese cedar and Japanese cypress pollinosis
Acronym	Immunological effects of sublingual immunotherapy with Japanese cedar pollen extract in Japanese cypress pollinosis
Scientific Title	Immunological effects of sublingual immunotherapy with Japanese cedar pollen extract in patients with combined Japanese cedar and Japanese cypress pollinosis
Scientific Title:Acronym	Immunological effects of sublingual immunotherapy with Japanese cedar pollen extract in Japanese cypress pollinosis
Region	Japan

Condition
Condition	combined Japanese cedar and Japanese cypress pollinosis
Classification by specialty	Clinical immunology Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Half of patients with combined Japanese cedar (JC) and Japanese cypress pollinosis have worsened symptoms after sublingual immunotherapy (SLIT) in cypress pollen season. Therefore, we examined the immunological effects of SLIT with standardized JC pollen extract in patients with combined JC and Japanese cypress pollinosis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Peripheral blood mononuclear cells (PBMCs) from patients with JC and Japanese cypress pollinosis who received SLIT with standardized JC pollen extract which was administered over a period of 1 to 2 years, were incubated with Cry j 1, Cha o 1 and Cha o 3 antigens. Antigen-induced production of IL-5, IL-10, IL-17 and IFN-g.
Key secondary outcomes	Serum concentrations of antigen-specific IgE and IgG4 were measured. A basophil activation test was also performed.

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	12 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	This prospective study included healthy controls, patients with combined JC and Japanese cypress pollinosis who were not treated with SLIT, and patients with combined pollinosis treated with SLIT.
Key exclusion criteria	The exclusion criteria were the presence or history of asthma or asthma-like symptoms.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Hirotaka Middle name Last name Kikuoka
Organization	Shiga University of Medical Science
Division name	Department of Otorhinolaryngology
Zip code	520-2192
Address	Seta-tsukinowa, Otsu, Shiga 520-2192, Japan
TEL	0775482111
Email	kikuoka@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Hirotaka Middle name Last name Kikuoka
Organization	Shiga University of Medical Science
Division name	Department of Otorhinolaryngology
Zip code	520-2192
Address	Seta-tsukinowa, Otsu, Shiga 520-2192, Japan
TEL	0775482111
Homepage URL
Email	kikuoka@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	This work was supported by Grant-in-Aid for Young Scientists, Japan.
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Shiga University of Medical Science
Address	Seta-tsukinowa, Otsu, Shiga 520-2192, Japan.
Tel	075482111
Email	rsupport@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 04 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	127
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	Completed
Date of protocol fixation	2018 Year 03 Month 14 Day
Date of IRB	2018 Year 03 Month 14 Day
Anticipated trial start date	2018 Year 03 Month 14 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Peripheral blood mononuclear cells (PBMCs) from patients with JC and Japanese cypress pollinosis who did (SLIT group) and did not (non-SLIT group) receive SLIT and from healthy controls were incubated with Cry j 1, Cha o 1 and Cha o 3 antigens. Antigen-induced production of IL-5, IL-10, IL-17 and IFN-g, and serum concentrations of antigen-specific IgE and IgG4 were measured. A basophil activation test was also performed.

Management information
Registered date	2019 Year 04 Month 03 Day
Last modified on	2019 Year 12 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041469