[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640219":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":38,"studyPopulation":39,"armGroups":40,"interventions":34,"overallOfficials":34,"centralContacts":50,"locations":56,"responsibleParty":72,"collaborators":34,"id":76,"slug":34,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":34,"enrollmentInfo":85,"targetDuration":34,"studyType":88,"phases":34,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":98,"whyStopped":34,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"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 \\\u003C24h, or hospitalization ≥24h); (2) no use of oral corticosteroids (OCS); (3) pre-bronchodilator FEV1 improvement ≥100 mL from baseline; (4) ACQ-6 score \\\u003C1.5 (or ≤0.75). The proportion of patients meeting all four criteria will be calculated.","48 weeks after the first dose of biologic",[14,18,21,25,28,31],{"measure":15,"description":16,"timeFrame":17},"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.","Baseline to 48 weeks",{"measure":19,"description":20,"timeFrame":17},"Change in pre-bronchodilator FEV1 (mL)","FEV1 (forced expiratory volume in 1 second) will be measured using spirometry according to international standards (ATS\u002FERS). Change in mL from baseline will be calculated at weeks 8, 16, and 48.",{"measure":22,"description":23,"timeFrame":24},"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 (\\\u003C24 hours), or hospitalization (≥24 hours). Rate = (total exacerbations × 365.25) \u002F follow-up days.","48 weeks",{"measure":26,"description":27,"timeFrame":17},"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.",{"measure":29,"description":30,"timeFrame":17},"Change in blood exosomal multi-omics biomarkers","Residual blood from routine tests (2-3 mL per time point at weeks 0,4,8,16,24,40,48) will be used to isolate exosomes. Transcriptomics (RNA-seq), proteomics (mass spectrometry), and metabolomics (LC-MS) profiles will be compared between baseline and week 48. Differentially expressed features (\\|log2FC\\|\\>1, FDR\\\u003C0.05) will be reported.",{"measure":32,"description":33,"timeFrame":17},"Change in lung radiomics features","For patients who undergo HRCT or Xe129MRI (optional), radiomics features (e.g., texture, shape, intensity) will be extracted using standard software. Changes from baseline to week 24 and 48 will be analyzed.",null,{"allocation":34,"interventionModel":34,"interventionModelDescription":34,"primaryPurpose":34,"observationalModel":36,"timePerspective":37,"maskingInfo":34},"COHORT","PROSPECTIVE","Firstly, eligible patients (age ≥14 years, diagnosis of severe eosinophilic ACOS, blood eosinophils ≥150\u002FμL within 3 months or ≥300\u002FμL 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.\n\nThen, 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.\n\nNext, 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 \\\u003C1.5 (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.\n\nFinally, statistical analyses include descriptive statistics, paired t-test\u002FWilcoxon, ANOVA\u002FKruskal-Wallis, mixed-effects model for repeated measures (MMRM), differential expression analysis (DESeq2\u002Flimma), 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.","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.",[41,44,47],{"label":42,"type":34,"description":43,"interventionNames":34},"Benralizumab Group","Patients with severe eosinophilic ACOS receiving benralizumab as prescribed by their treating physician according to routine clinical practice.",{"label":45,"type":34,"description":46,"interventionNames":34},"Mepolizumab Group","Patients with severe eosinophilic ACOS receiving mepolizumab as prescribed by their treating physician according to routine clinical practice.",{"label":48,"type":34,"description":49,"interventionNames":34},"Dupilumab Group","Patients with severe eosinophilic ACOS receiving dupilumab as prescribed by their treating physician according to routine clinical practice.",[51],{"name":52,"role":53,"phone":54,"phoneExt":34,"email":55},"Qi Huang","CONTACT","+86 15827329098","huangqi66@126.com",[57],{"facility":58,"status":34,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Union hospital, Tongji Medical college, Huazhong University of Science and Technology","Wuhan","Hubei","430022","China","CN",{"type":65,"coordinates":66},"Point",[67,68],114.26667,30.58333,{"lat":68,"lon":67},[71],{"name":52,"role":53,"phone":54,"phoneExt":34,"email":55},{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Yang Jin","Subdecanal,Professor and Director of Respiratory and Critical Care Medicine, Chief Investigator","100640219",false,"NCT07602881","Blood Exosomal Multi-omics and Lung Radiomics for Predicting Efficacy and Prognosis of Severe Eosinophilic ACOS With Biologics","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","ACOS","Inclusion Criteria:\n\n* Age ≥ 14 years\n* Clinician decision to start biologic (benralizumab, mepolizumab, or dupilumab) for severe eosinophilic ACOS\n* Blood eosinophils ≥150\u002FμL within 3 months prior to informed consent, or ≥300\u002FμL within 1 year prior\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Currently participating in any other interventional clinical trial\n* Known allergy or hypersensitivity to any component of the study drugs\n* Any type of malignancy\n* Prior or current biologic treatment for ACOS","ALL","14 Years",{"count":86,"type":87},500,"ESTIMATED","OBSERVATIONAL","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.",[91],"Severe Eosinophilic ACOS (Asthma-COPD Overlap)",[93,94,95,96,97],"Biomarker","Exosomal Multi-omics","Radiomics","Biologics","Severe Eosinophilic ACOS","NOT_YET_RECRUITING","2026-05-21",{"date":101,"type":102},"2026-05-22","ACTUAL",{"date":104,"type":87},"2026-06-01",{"date":106,"type":87},"2028-07-01",{"name":5,"class":6},1]