Tokyo, Dec. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060091) titled 'A long-term observational study of real-world use of biologics and predictors of treatment response in adults with severe asthma' on Dec. 15.

Study Type: Observational

Primary Sponsor: Institute - Teikyo University School of Medicine

Condition: Condition - Asthma Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - In recent years, multiple biologic agents have become available for the treatment of adults with severe asthma. However, the biologic agent that provides the greatest clinical benefit (best response) differs among individual patients, and many patients require sequential use of multiple agents before reaching the optimal treatment. Clinical characteristics and biomarkers that predict the best-response biologic have not been sufficiently established. In addition, driven by the high efficacy of biologic therapies, clinical remission -defined by absence of exacerbations, good symptom control, no continuous oral corticosteroid (OCS) use, and optimization of lung function- has gained attention as a new treatment goal. Nevertheless, information on the achievement, durability, and predictors of clinical remission in Japan remains limited. This study aims to longitudinally follow patients with and without biologic therapy to: 1) identify baseline factors associated with the best-response biologic, 2) clarify the achievement and predictors of clinical remission with the final biologic agent used, and 3) evaluate the long-term effects of biologic therapy on clinical remission, lung function, and HRCT findings. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Biologic-treated patients: baseline clinical data available at initiation of the first biologic agent Non-biologic-treated patients: receiving the highest approved dose of inhaled corticosteroids plus at least one bronchodilator Able to complete questionnaire-based assessments Good treatment adherence (>= approximately 70% of prescribed medications) Written informed consent obtainable Key exclusion criteria - Eosinophilic granulomatosis with polyangiitis (EGPA), allergic bronchopulmonary aspergillosis (ABPA), hypereosinophilic syndrome (HES), eosinophilic pneumonia, or eosinophilic bronchiolitis Concomitant diseases requiring systemic corticosteroids or molecular targeted therapy (e.g., collagen vascular diseases, interstitial lung disease) Ongoing treatment for malignant disease Inability or difficulty in providing informed consent Considered inappropriate for participation by the principal investigator Target Size - 450

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 03 Month 19 Day Date of IRB - 2025 Year 03 Month 19 Day Anticipated trial start date - 2025 Year 03 Month 19 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068725

Disclaimer: Curated by HT Syndication.