UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056422 |
|---|---|
| Receipt number | R000064469 |
| Scientific Title | Efficacy and safety analysis of pre-co-seasonal sublingual immunotherapy for Japanese cedar pollinosis: A multicenter randomized parallel-group comparative trial |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2025/06/11 09:09:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy and safety analysis of pre-co-seasonal sublingual immunotherapy for Japanese cedar pollinosis
Acronym
PC-SLIT for JCP
Scientific Title
Efficacy and safety analysis of pre-co-seasonal sublingual immunotherapy for Japanese cedar pollinosis: A multicenter randomized parallel-group comparative trial
Scientific Title:Acronym
PC-SLIT for JCP
Region
| Japan |
Condition
Condition
Japanese cedar pollinosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Currently, sublingual immunotherapy for Japanese cedar pollinosis, which is a curative treatment, is administered throughout the year. However, in other countries, pre-co-seasonal sublingual immunotherapy (PC-SLIT), which is administered from three months before the pollen season to during the pollen season, is mainstream, and its efficacy and safety have been demonstrated. This study aims to evaluate the efficacy and safety of PC-SLIT for Japanese cedar pollonosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total nasal symptom score over one Week during the peak of the pollen season
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Pre-co-seasonal sublingual immunotherapy
Interventions/Control_2
Year-round 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.Patients with Japanese cedar pollinosis who started sublingual immunotherapy with cedar sublingual tablets (Cedarcure) during the year 2024
2.Patients who are maintained on sublingual immunotherapy with Cedarcure 5,000 JAU tablets
3.Patients with a serum cedar-specific IgE class of 2 or higher
4.Patients who can obtain written consent from themselves to participate in the study of their own free will
5.Patients who are 5 years or older at the time of consent
6.Gender: Not specified
7.Outpatient
Key exclusion criteria
1.Women who are pregnant or may become pregnant
2.Patients diagnosed with cancer
3.Patients taking oral steroids (more than 10 mg/day of prednisolone for more than two consecutive weeks)
4.Patients receiving omalizumab, dupilumab, mepolizumab, benralizumab, or tezepelumab
5.Patients with severe asthma
6.Patients with a history of anaphylaxis
7.Patients with a history of hypersensitivity to adrenaline
8.Patients judged to have complications or infections that affect the heart, liver, kidneys, blood diseases, or other conditions that could impact the conduct of the study
9.Patients deemed unsuitable for study participation by the investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Okano |
Organization
International University of Health and Welfare
Division name
Otorhinolaryngology, Head and Neck Surgery
Zip code
2868686
Address
852 Hatakeda, Narita
TEL
0476-35-5600
mokano@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Maiko |
| Middle name | |
| Last name | Maruyama |
Organization
International University of Health and Welfare
Division name
Otorhinolaryngology, Head and Neck Surgery
Zip code
2868686
Address
852 Hatakeda, Narita
TEL
0476-35-5600
Homepage URL
maruyama-maiko-kj@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare Ethics Review Board for Clinical Research
Address
852 Hatakeda, Narita
Tel
0476-35-5600
rinri_md@iuhw.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 | 01 | Month | 01 | 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
89
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 10 | Day |
Last modified on
| 2025 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064469
