Severe Eosinophilic ACOS (Asthma-COPD Overlap)ACOSNCT07602881
Blood Exosomal Multi-omics and Lung Radiomics for Predicting Efficacy and Prognosis of Severe Eosinophilic ACOS With Biologics
An observational study of Severe Eosinophilic ACOS (Asthma-COPD Overlap), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Severe Eosinophilic ACOS (Asthma-COPD Overlap)
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 1 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Union hospital, Tongji Medical college, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Qi Huang, +86 15827329098, huangqi66@126.com
About this study
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
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.
Read the 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.
- Keywords
- Biomarker, Exosomal Multi-omics, Radiomics, Biologics, Severe Eosinophilic ACOS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 weeks after the first dose of biologic
Secondary outcomes (6)
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.
Measured: Baseline to 48 weeks
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.
Measured: Baseline to 48 weeks
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.
Measured: 48 weeks
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.
Measured: Baseline to 48 weeks
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<0.05) will be reported.
Measured: Baseline to 48 weeks
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.
Measured: Baseline to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Eosinophilic ACOS (Asthma-COPD Overlap)Studies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Jin, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602881
- Sponsor's protocol ID
- XHJY202605
- Acronym
- ACOS
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07602881
- Acronym / sponsor ID
- ACOS / XHJY202605
- Keywords
- Biomarker, Exosomal Multi-omics, Radiomics, Biologics, Severe Eosinophilic ACOS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite efficacy and prognosis endpoint at week 48 in severe eosinophilic ACOS
Time frame: 48 weeks after the first dose of biologic
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Eosinophilic ACOS (Asthma-COPD Overlap), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qi Huang (+86 15827329098, huangqi66@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite efficacy and prognosis endpoint at week 48 in severe eosinophilic ACOS (time frame: 48 weeks after the first dose of biologic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.