Tokyo, June 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061957) titled 'Association of Peripheral Blood Mast Cell Progenitors 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 - Saga University

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

Objective: Narrative objectives1 - Bronchial asthma affects approximately one million individuals in Japan. Although biologic therapies targeting type 2 (T2) inflammation, including IL-5, IL-4/13, and thymic stromal lymphopoietin (TSLP), have improved the management of severe asthma, some patients remain refractory to these treatments. Therefore, the identification of novel biomarkers and therapeutic targets for difficult-to-treat asthma remains an unmet need.

Mast cells are key immune cells involved in the pathogenesis of asthma and play important roles in T2 inflammatory responses. However, their clinical significance and contribution to treatment responsiveness are not fully understood.

Our preliminary studies suggest that mast cell progenitors and their related molecules may serve as novel biomarkers and therapeutic targets for severe asthma. Based on these findings, we designed 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 06 Month 11 Day Date of IRB - 2026 Year 06 Month 11 Day Anticipated trial start date - 2026 Year 06 Month 11 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=R000070894

Disclaimer: Curated by HT Syndication.