UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057424 |
|---|---|
| Receipt number | R000065613 |
| Scientific Title | Analysis of IL-27 - mediated Regulatory Activity in Tr1 cells of Patients in mild asthma |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/27 15:47:22 |
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Basic information
Public title
Exploring the Link Between Immune Imbalance and IL-27 in Asthma
Acronym
Asthma Immune Regulation and IL-27 Study
Scientific Title
Analysis of IL-27 - mediated Regulatory Activity in Tr1 cells of Patients in mild asthma
Scientific Title:Acronym
Analysis of IL-27 regulation of Tr1 cells in asthma
Region
| Japan |
Condition
Condition
Atopic mild asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the Jak/Stat activity of peripheral blood Tr1 cells stimulated with IL-27 and to compare the results between asthmatic and non-asthmatic patients.
Basic objectives2
Others
Basic objectives -Others
To investigate the Jak/Stat activity of peripheral blood Tr1 cells stimulated with IL-27
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is to investigate the regulatory activity of IL-27 in Tr1 cells by evaluating the frequency of IL-27 receptor expression and phosphorylated STAT1/STAT3.
Key secondary outcomes
The secondary endpoint is to investigate the correlation between the regulatory activity of IL-27 in Tr1 and the following items
(airway hyperresponsiveness, peripheral blood eosinophils, FENO, lung function).
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Atopic mild asthmatics and non-atopic non asthmatics
2. Never smokers
Key exclusion criteria
1. Unable to undergo pulmonary function tests
2. Pregnant, possibly pregnant, or nursing
3. Participants who judged that the research directors and researchers were inappropriate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masanobu |
| Middle name | |
| Last name | Matsuoka |
Organization
Kurume University
Division name
Division of Respirology, Neurology and Rheumatology, Department of Medicine, Kurume University School of Medicine
Zip code
830-0011
Address
67 Asahi-machi, Kurume, Fukuoka, Japan
TEL
0942-31-7560
matsuoka_masanobu@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Masanobu |
| Middle name | |
| Last name | Matsuoka |
Organization
Kurume University
Division name
Division of Respirology, Neurology and Rheumatology, Department of Medicine, Kurume University Schoo
Zip code
830-0011
Address
67 Asahi-machi, Kurume, Fukuoka, Japan
TEL
0942-31-7560
Homepage URL
matsuoka_masanobu@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
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
Kurume University
Address
67 Asahi-machi, Kurume, Fukuoka, Japan
Tel
0942-31-7560
matsuoka_masanobu@kurume-u.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 | 04 | 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
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
| 2025 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Management information
Registered date
| 2025 | Year | 03 | Month | 27 | Day |
Last modified on
| 2025 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065613
