Firstly, to screen blood exosomal multi-omics (transcriptomics, proteomics, metabolomics) and lung radiomics (HRCT, Xe129MRI) biomarkers that can predict efficacy and prognosis in severe eosinophilic ACOS (asthma-COPD overlap) patients treated with different biologics (benralizumab, mepolizumab, dupilumab). Then, to prospectively follow patients for 48 weeks after biologic initiation and collect clinical data, blood samples, and imaging features. Finally, to build a multi-dimensional predictive model for efficacy and prognosis of severe eosinophilic ACOS.
Age ≥ 14 years
Clinician decision to start biologic (benralizumab, mepolizumab, or dupilumab) for severe eosinophilic ACOS
Blood eosinophils ≥150/μL within 3 months prior to informed consent, or ≥300/μL within 1 year prior
Signed written informed consent
Currently participating in any other interventional clinical trial
Known allergy or hypersensitivity to any component of the study drugs
Any type of malignancy
Prior or current biologic treatment for ACOS
Patients aged 14 years or older with a confirmed diagnosis of severe eosinophilic ACOS (asthma-COPD overlap) who are prescribed a biologic (benralizumab, mepolizumab, or dupilumab) by their treating physician according to routine clinical practice. The study population is recruited from outpatient and inpatient respiratory departments of multiple hospitals in China, including Union Hospital (Tongji Medical College, Huazhong University of Science and Technology) and its collaborating centers.
Cohort
Prospective
Not listed
Composite efficacy and prognosis endpoint at week 48 in severe eosinophilic ACOS
We define the composite endpoint as achieving ALL of the following at week 48: (1) no ACOS exacerbation (worsening of respiratory symptoms requiring systemic corticosteroids ≥3 days, emergency visit \<24h, or hospitalization ≥24h); (2) no use of oral corticosteroids (OCS); (3) pre-bronchodilator FEV1 improvement ≥100 mL from baseline; (4) ACQ-6 score \<1.5 (or ≤0.75). The proportion of patients meeting all four criteria will be calculated.
Change in Asthma Control Questionnaire-6 (ACQ-6) score
ACQ-6 is a validated questionnaire (6 items, score 0-6, lower = better control). Change from baseline will be assessed at weeks 1,2,4,8,16,24,40,48. Mean difference and standard deviation will be reported.
Change in pre-bronchodilator FEV1 (mL)
FEV1 (forced expiratory volume in 1 second) will be measured using spirometry according to international standards (ATS/ERS). Change in mL from baseline will be calculated at weeks 8, 16, and 48.
Annualized rate of ACOS exacerbations
Number of ACOS exacerbations per year during the 48-week follow-up. Exacerbation defined as worsening of respiratory symptoms requiring systemic corticosteroids (≥3 days), emergency department visit (\<24 hours), or hospitalization (≥24 hours). Rate = (total exacerbations × 365.25) / follow-up days.
Change in Mini Asthma Quality of Life Questionnaire (MiniAQLQ) score
MiniAQLQ is a 15-item questionnaire (score 1-7, higher = better quality of life). Change from baseline will be assessed at weeks 8, 16, 24, and 48.
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