UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036402
Receipt number 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 14:17:28

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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 or person

Institute

Shiga University of Medical Science

Institute

Department

Personal name



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

Value
https://center6.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