UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061958 |
|---|---|
| Receipt number | R000070893 |
| Scientific Title | Association of Peripheral Blood Basophils and Their Related Molecules with Clinical Characteristics in Healthy Individuals and Patients with Bronchial Asthma |
| Date of disclosure of the study information | 2026/06/18 |
| Last modified on | 2026/06/18 09:15:50 |
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Basic information
Public title
Association of Peripheral Blood Basophils and Their Related Molecules with Clinical Characteristics in Healthy Individuals and Patients with Bronchial Asthma
Acronym
Peripheral Blood Basophils and Related Molecules
Scientific Title
Association of Peripheral Blood Basophils and Their Related Molecules with Clinical Characteristics in Healthy Individuals and Patients with Bronchial Asthma
Scientific Title:Acronym
Peripheral Blood Basophils and Related Molecules
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Bronchial asthma affects approximately one million individuals in Japan. Despite advances in standard therapies, treatment-resistant asthma still accounts for 5-10% of cases and remains a major healthcare challenge because of frequent exacerbations, impaired quality of life (QOL), and increased medical costs.
Biologic therapies targeting type 2 (T2) inflammation pathways, including IL-5, IL-4/13, and thymic stromal lymphopoietin (TSLP), have improved the management of severe asthma. However, a substantial proportion of patients remain refractory to these treatments, highlighting the urgent need for biomarkers that can identify difficult-to-treat asthma, particularly non-T2 inflammatory asthma, as well as novel therapeutic targets.
Basophils are immune cells implicated in asthma pathogenesis. Through IL-4 production, tissue localization, and cytokine responsiveness, they have been suggested to play important roles in immune responses beyond classical T2 inflammation. Nevertheless, their pathological significance and contribution to treatment responsiveness remain poorly understood.
Our preliminary studies suggest that basophils and their associated molecules may serve as novel biomarkers and therapeutic targets for severe asthma beyond T2 inflammation. These findings provided the rationale for the present study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison and Association of Peripheral Blood Basophils and Basophil-Related Molecules among Healthy Individuals, Patients with Mild Asthma, and Patients with Severe Asthma
Key secondary outcomes
Association of Peripheral Blood Basophils and Basophil-Related Molecules with Asthma Severity, Treatment Profiles, Clinical Symptoms, and Pulmonary Function
Predictive Analysis of Asthma Severity, Clinical Symptoms, Pulmonary Function, and Biologic Treatment Response Using an Integrated Model of Peripheral Blood Eosinophils, FeNO, and Basophils
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Healthy volunteers will be evaluated without any treatment.
Interventions/Control_2
Patients with mild asthma will be evaluated under their current treatment regimen.
Interventions/Control_3
Tezepelumab will be administered to patients with severe asthma for six months.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Individuals who meet one of the following criteria:
Healthy volunteers
Patients with mild asthma
Patients with severe asthma scheduled to receive biologic therapy
2. Age 20 years or older
3. Provision of written informed consent for participation in the study
Key exclusion criteria
Individuals with severe hepatic or renal impairment
Individuals who are pregnant, may be pregnant, are breastfeeding, or plan to become pregnant during the study period
Individuals deemed unsuitable for participation in the study by the investigator
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Tashiro |
Organization
Saga University Hospital
Division name
Respiratory Medicine
Zip code
8498501
Address
5-1-1 Nabeshima, Saga
TEL
0952342369
si3222@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Tashiro |
Organization
Saga University Hospital
Division name
Respiratory Medicine
Zip code
8498501
Address
5-1-1 Nabeshima, Saga
TEL
0952-34-2369
Homepage URL
si3222@cc.saga-u.ac.jp
Sponsor or person
Institute
Sag University
Institute
Department
Personal name
Hiroki Tashiro
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Saga University Hospital
Address
5-1-1 Nabeshima, Saga
Tel
0952342369
si3222@cc.saga-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2025-12-02
Org. issuing International ID_1
Clinical Research Center, Saga University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Not required for this country
Institutions
Institutions
佐賀大学医学部附属病院（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2029 | Year | 05 | 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
| 2026 | Year | 06 | Month | 18 | Day |
Last modified on
| 2026 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070893
