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
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
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
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
