Tokyo, June 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061958) titled 'Association of Peripheral Blood Basophils and Their Related Molecules with Clinical Characteristics in Healthy Individuals and Patients with Bronchial Asthma' on June 18.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Sag University

Condition: Condition - Asthma Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 70

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070893

Disclaimer: Curated by HT Syndication.