A long-term observational study of real-world use of biologics and predictors of treatment response in adults with severe asthma

A multicenter observational study of real-world biologic treatment patterns, best response, and clinical remission and their predictors in adults with severe asthma - J-PREDICT

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060091

Enrollment

450

Registered

2025-12-15

Start date

2025-03-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Baseline factors associated with being a best-response biologic agent (GETE >= good) Achievement of clinical remission with the best-response biologic agent Baseline factors associated with achievement of clinical remission with the best-response biologic agent	—

Secondary

Measure	Time frame
Real-world treatment flow of biologic agents and frequency of best-response biologics Subgroup analyses by prior treatments Predictive factors for response at biologic switching and epidemiology/predictors of successful treatment discontinuation Differences in biomarkers between patients with and without clinical remission Longitudinal changes in clinical remission status, lung function, and HRCT findings comparing biologic-treated and non-treated patients	—

Measure

Time frame

Real-world treatment flow of biologic agents and frequency of best-response biologics Subgroup analyses by prior treatments Predictive factors for response at biologic switching and epidemiology/predictors of successful treatment discontinuation Differences in biomarkers between patients with and without clinical remission Longitudinal changes in clinical remission status, lung function, and HRCT findings comparing biologic-treated and non-treated patients

—

Countries

Japan

Contacts

Public ContactHiroyuki Nagase

Teikyo University School of Medicine Division of Respiratory Medicine and Allergology, Department of Medicine

nagaseh@med.teikyo-u.ac.jp+81-3-3964-1211

Outcome results