UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058457 |
|---|---|
| Receipt number | R000066844 |
| Scientific Title | Exploring factors influencing the efficacy of cedar pollinosis immunotherapy |
| Date of disclosure of the study information | 2025/07/20 |
| Last modified on | 2025/07/14 14:14:56 |
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Basic information
Public title
What factors influence the effectiveness of cedar pollinosis immunotherapy?
Acronym
What are the efficacy factors for cedar pollinosis immunotherapy?
Scientific Title
Exploring factors influencing the efficacy of cedar pollinosis immunotherapy
Scientific Title:Acronym
Efficacy factors for cedar pollinosis immunotherapy
Region
| Japan |
Condition
Condition
Japanese cedar pollinosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate the factors influencing the efficacy of sublingual immunotherapy. By clarifying the differences in efficacy between children and adults, the aim is to establish guidelines to determine whether sublingual immunotherapy is indicated in the pre-treatment phase for hay fever patients of all ages.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Characterisation and genetic analysis of blood cells isolated from blood and analysis of proteins in serum and oral flora in saliva in the effective and ineffective immunotherapy groups.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
For the immunotherapy group, cedar pollen allergy patients with positive serum cedar pollen-specific IgE, aged 5 years and over who opted for treatment with Cidacure cedar pollen sublingual tablets.
Interventions/Control_2
For the drug treatment group, cedar pollen allergy patients with positive serum cedar pollen-specific IgE, aged 5 years and over, who opted for treatment with a therapeutic agent other than sublingual immunotherapy.
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
1. for the immunotherapy group, cedar pollen allergy patients with positive serum cedar pollen-specific IgE, aged 5 years and over who opt for treatment with Cidacure cedar pollen sublingual tablets
2. for the drug treatment group, cedar pollen allergy patients with positive serum cedar pollen-specific IgE, aged 5 years and over who opted for treatment with a therapeutic agent other than sublingual immunotherapy
3. for the control group, non-allergic rhinitis patients with negative serum IgE antibodies, aged 15 years and over who are continuing in-patient treatment for symptom relief
4. those who have been informed about the study using the consent document and have given their consent.
Key exclusion criteria
1. persons who have developed allergic symptoms as a result of diagnosis or treatment with allergen extracts or consumption of foods containing cedar pollen
2. persons who currently suffer from bronchial asthma .
3. persons with malignant tumours or systemic diseases affecting the immune system.
4. persons with wounds or inflammation in the oral cavity or after oral surgery such as tooth extraction
5. persons on non-selective beta-blockers
6. persons on tricyclic antidepressants and monoamine oxidase inhibitors
7. persons with severe cardiac or pulmonary disease and hypertension
8. persons receiving systemic steroids
9. pregnant or lactating women
10. persons with a history or illness that adversely affects immunotherapy
11. any other person who is deemed by the principal investigator or a research partner to be unsuitable to participate in this study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Gotoh |
| Middle name | |
| Last name | Minoru |
Organization
Nippon Medical School
Division name
Dept. of Otorhinolaryngology
Zip code
1138603
Address
1-1-5 Sendagi Bunkyo-ku Tokyo, Japan
TEL
0338222131
m.gotoh@nms.ac.jp
Public contact
Name of contact person
| 1st name | Minoru |
| Middle name | |
| Last name | Gotoh |
Organization
Nippon Medical School
Division name
Dept. of Otorhinolaryngology
Zip code
107-0062
Address
1-1-5 Sendagi Bunkyo-ku Tokyo, Japan
TEL
0334063470
Homepage URL
m.gotoh@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School
Address
1-1-5 Sendagi Bunkyo-ku Tokyo, Japan
Tel
0338222131
chuorinri.group@nms.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
| 2025 | Year | 07 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 14 | Day |
Last modified on
| 2025 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066844
