Tokyo, Sept. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062991) titled 'Exploration of Novel Biomarkers Associated with Treatment Response to Biologics in Severe Asthma' on Sept. 20.
Study Type:
Observational
Primary Sponsor:
Institute - Keio University School
Condition:
Condition - Severe asthma, refractory asthma
Classification by malignancy - Others
Genomic information - YES
Objective:
Narrative objectives1 - This prospective, single-center observational study enrolls patients with severe asthma treated with biologic agents. Biological samples (sputum, blood, nasal brushing, stool) are collected for multi-omics analysis and for analysis of lymphocytes, eosinophils, and epithelial cells; treatment response to biologics is assessed using asthma symptom and QOL questionnaires and lung-function testing. Integrating these data, the aim is to identify novel biomarkers correlated with the efficacy of biologics in severe asthma. The principal measure of treatment effect is the change in ACQ-6 from baseline at 24 weeks. As secondary/exploratory analyses, the proportion achieving clinical remission at 24 weeks (a composite of no maintenance OCS, no exacerbation requiring systemic corticosteroids, ACQ-6 = 80%, and persistence of exacerbations, residual symptoms, or lung-function decline despite >= 3 months of ICS >= 500 microg/day fluticasone-propionate equivalent plus at least one long-term controller (LABA, leukotriene receptor antagonist, inhaled anticholinergic, or theophylline).
3. Aged 20 years or older at the time of consent.
4. Written informed consent obtained.
Key exclusion criteria - 1. Contraindication to biologic therapy (history of hypersensitivity to a biologic agent).
(Note: for patients switching from another biologic, an interval of at least 4 weeks between the previous and the new biologic is required.)
Target Size - 200
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2022 Year 02 Month 09 Day
Date of IRB - 2022 Year 05 Month 09 Day
Anticipated trial start date - 2022 Year 09 Month 01 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071910
Disclaimer: Curated by HT Syndication.
