Bronchial asthma
Conditions
Interventions
None listed
Sponsors
National Mie Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study Group (Target1): Participants must meet all three of the following criteria: Asthma patients aged between 6 and 50 years. Patients experiencing uncontrolled asthma or exacerbations requiring systemic corticosteroid treatmentdespite the use of medium- or high-dose inhaled corticosteroids (ICS) in combination with other long-term controller medications, and who are eligiblefor biologic therapy under health insurance coverage. Patients who are either currently receiving biologic therapy* at the time of enrollment or have been scheduled to initiate biologic therapy. Control Group (Target2): Participants must meet all three of the following criteria (serving as the comparator to Target 1): Asthma patients aged between 6 and 50 years. Patients experiencing uncontrolled asthma or exacerbations requiring systemiccorticosteroid treatment despite the use of medium- or high-dose ICS in combination with other long-term controller medications, or those exhibiting aprogressive decline in pulmonary function over time. Patients who have not received biologic therapy* for asthma at the time of enrollment and do not haveimmediate plans to initiate such treatment. * Biologic therapy refers to any of the following monoclonal antibodies: Omalizumab, Mepolizumab, Benralizumab, Dupilumab, Tezepelumab
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTakahiro Nishida
National Mie Hospital Department of Pediatrics and Allergy
Outcome results
None listed