Blood Exosomal Multi-omics and Lung Radiomics for Predicting Efficacy and Prognosis of Severe Eosinophilic ACOS With Biologics

NCT07602881 | Not Yet Recruiting

• 1 other identifier: XHJY202605
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Eosinophilic ACOS (Asthma-COPD Overlap)

Keywords

Biomarker; Exosomal Multi-omics; Radiomics; Biologics; Severe Eosinophilic ACOS

Outcome Measures

Primary Outcomes (1)

• 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.

  48 weeks after the first dose of biologic

Secondary Outcomes (6)

• Change in Asthma Control Questionnaire-6 (ACQ-6) score

  Baseline to 48 weeks

• Change in pre-bronchodilator FEV1 (mL)

  Baseline to 48 weeks

• Annualized rate of ACOS exacerbations

  48 weeks

• Change in Mini Asthma Quality of Life Questionnaire (MiniAQLQ) score

  Baseline to 48 weeks

• Change in blood exosomal multi-omics biomarkers

  Baseline to 48 weeks

Study Arms (3)

Benralizumab Group

Patients with severe eosinophilic ACOS receiving benralizumab as prescribed by their treating physician according to routine clinical practice.

Mepolizumab Group

Patients with severe eosinophilic ACOS receiving mepolizumab as prescribed by their treating physician according to routine clinical practice.

Dupilumab Group

Patients with severe eosinophilic ACOS receiving dupilumab as prescribed by their treating physician according to routine clinical practice.

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union hospital, Tongji Medical college, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Residual peripheral blood after routine testing (2-3 mL per time point, up to 7 time points) will be used for exosome isolation. Exosomes are stored at -80°C for subsequent transcriptomics, proteomics, and metabolomics analysis.

Central Study Contacts

Qi Huang

CONTACT

+86 15827329098; huangqi66@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Subdecanal,Professor and Director of Respiratory and Critical Care Medicine, Chief Investigator

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

CN (1)