Blood Exosomal Multi-omics and Lung Radiomics for Predicting Efficacy and Prognosis of Severe Eosinophilic ACOS With Biologics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Severe Eosinophilic ACOS (Asthma-COPD Overlap). Basic parameters: from 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Blood Exosomal Multi-omics and Lung Radiomics for Predicting Efficacy and Prognosis of Severe Eosinophilic ACOS (Asthma-COPD Overlap Syndrome) Treated With Different Biologics: A Real-World Observational Study
Overview
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.
Detailed description
Firstly, eligible patients (age ≥14 years, diagnosis of severe eosinophilic ACOS, blood eosinophils ≥150/μL within 3 months or ≥300/μL within 1 year, and clinician decision to start a biologic) will be enrolled. Exclusion criteria include concurrent trial participation, allergy to biologics, malignancy, or prior biologic use.
Then, patients are followed for 48 weeks after the first biologic dose. Visits occur at weeks 0, 1, 2, 4, 8, 16, 24, 40, and 48. Data collected include demographics, medical history, ACQ-6, MiniAQLQ, pre-BD FEV1, exacerbations, medication use, adverse events, and blood routine tests (residual samples for exosome analysis). HRCT and Xe129MRI are optional.
Next, the primary outcome is the composite endpoint of efficacy and prognosis at week 48, defined as: no ACOS exacerbation, no oral corticosteroids, pre-BD FEV1 improvement ≥100 mL from baseline, and ACQ-6 score \<1.5 (or ≤0.75). Secondary outcomes include changes in ACQ-6, FEV1, annualized exacerbation rate, MiniAQLQ, OCS dose reduction, and blood exosomal multi-omics and lung radiomics biomarkers.
Finally, statistical analyses include descriptive statistics, paired t-test/Wilcoxon, ANOVA/Kruskal-Wallis, mixed-effects model for repeated measures (MMRM), differential expression analysis (DESeq2/limma), pathway enrichment, machine learning (LASSO, random forest), ROC curves, logistic regression, and Cox regression. A total of 500 patients will be enrolled from multiple centers in China.
Primary outcome measures
- Composite efficacy and prognosis endpoint at week 48 in severe eosinophilic ACOS [Time frame: 48 weeks after the first dose of biologic]
Secondary outcome measures (6)
- Change in Asthma Control Questionnaire-6 (ACQ-6) score [Time frame: Baseline to 48 weeks]
- Change in pre-bronchodilator FEV1 (mL) [Time frame: Baseline to 48 weeks]
- Annualized rate of ACOS exacerbations [Time frame: 48 weeks]
- Change in Mini Asthma Quality of Life Questionnaire (MiniAQLQ) score [Time frame: Baseline to 48 weeks]
- Change in blood exosomal multi-omics biomarkers [Time frame: Baseline to 48 weeks]
- Change in lung radiomics features [Time frame: Baseline to 48 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Union hospital, Tongji Medical college, Huazhong University of Science and Technology — Wuhan
Identifiers
NCT: NCT07602881 · XHJY202605