Tokyo, Jan. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060530) titled 'Survey on the Background of Asthma Patients Who Discontinued Biological Agents' on Jan. 30.

Study Type: Observational

Primary Sponsor: Institute - St. Francis Franciscan Social Medical Corporation, Himeji St. Mary's Hospital

Condition: Condition - bronchial asthma Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Primary Endpoint The primary objective is to investigate the main reasons for discontinuing biologic agents through a questionnaire.

Secondary Endpoints Duration of biologic agent use, type of agent used, and whether self-injection was performed.

Use of maintenance or intermittent oral corticosteroids (OCS).

ACT scores at initiation and discontinuation, blood eosinophil count at initiation, IgE levels, FeNO levels, and comorbidities.

Asthma control status after discontinuation (e.g., exacerbations, emergency department visits, and changes in inhaler prescriptions).

Utilization of financial support systems, such as the High-Cost Medical Expense Relief Program. Basic objectives2 - Bio-availability

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Age 18 years or older at the time of providing informed consent.

Adult asthma patients who have been treated with biologic agents (Xolair, Nucala, Fasenra, Dupixent, or Tezspire).

Patients who have discontinued biologic agents for 3 months or longer and are currently visiting the study institution.

Written informed consent has been obtained from the subject for participation in this study. Key exclusion criteria - Patients with dementia or psychiatric disorders requiring medical treatment, or patients in a comatose state.

Patients judged by the principal investigator to be unsuitable for participation in this study. Target Size - 20

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2025 Year 10 Month 01 Day Date of IRB - 2025 Year 11 Month 20 Day Anticipated trial start date - 2025 Year 11 Month 20 Day Last follow-up date - 2026 Year 02 Month 18 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069244

Disclaimer: Curated by HT Syndication.