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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036402
Receipt No. R000041469
Scientific Title Immunological effects of sublingual immunotherapy with Japanese cedar pollen extract in patients with combined Japanese cedar and Japanese cypress pollinosis
Date of disclosure of the study information 2019/04/04
Last modified on 2019/12/06

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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