Impact of Biologics for Recovering Outcomes and Improving Productivity Goodness in High-risk Trajectory cohort of Severe Pediatric and Young Adult Severe Asthma Study

UMIN ID: UMIN000056987

Registered date:10/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Bronchial asthma
• Date of first enrollment: 2024/12/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: 1.Proportion of patients achieving clinical remission 2.Longitudinal changes in pulmonary function 3.Morphological assessment via high-resolution computed tomography (HRCT) 4.Health economic evaluation, including productivity considerations

Key inclusion & exclusion criteria

• Age minimum: 6years-old
• Age maximum: 50years-old
• Gender: Male and Female
• Exclude criteria: Participants meeting any of the following criteria will be excluded from the study: Patientsreceiving (or scheduled to receive) any of the aforementioned biologic agents* for indications other than asthma** under health insurance coverage.Patients currently receiving (or scheduled to receive) immunosuppressive agents other than corticosteroids, such as oral Janus kinase (JAK)inhibitors or oral calcineurin inhibitors. Patients diagnosed with autoimmune diseases or malignancies at the time of enrollment (cases in which theseconditions newly develop during the observation period will not be excluded).Cases deemed inappropriate for study participation by the principal investigator or co-investigators. * Biologic agents include omalizumab,mepolizumab, benralizumab, dupilumab, and tezepelumab. ** Non-asthma indications include chronic spontaneous urticaria, seasonal allergicrhinitis, eosinophilic granulomatosis with polyangiitis, atopic dermatitis, chronic rhinosinusitis with nasal polyps, and nodular prurigo.

Related Information

• Primary Sponsor: National Mie Hospital
• Source(s) of Monetary Support: Environmental Restoration and Conservation Agency