Quantitative Chest CT and Multi-Omics to Distinguish Asthma From COPD and Predict Treatment Response
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorKorea University Guro Hospital
About this trial
This study aims to improve the diagnosis and treatment prediction of asthma and chronic obstructive pulmonary disease (COPD) by combining quantitative chest computed tomography (CT) imaging with multi-omics data.
Adults with asthma or COPD will be enrolled and undergo routine clinical evaluations, pulmonary function tests, blood tests, and chest CT scans. Additional samples, such as sputum and microbiome specimens, may also be collected. No experimental drugs or devices will be administered as part of this study.
Researchers will analyze CT imaging features together with clinical, laboratory, and biological data to better distinguish asthma from COPD and to identify factors that may predict treatment response. The findings are expected to contribute to more precise and personalized management of chronic airway diseases.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥19 years
COPD group: post-bronchodilator FEV1/FVC < 0.70
Asthma group: clinically confirmed diagnosis of asthma by a physician
Able to provide voluntary written informed consent
Disqualifiers
Acute exacerbation or active lower respiratory tract infection (e.g., pneumonia) within the past 4 weeks
Pregnancy or breastfeeding
Inability to undergo chest CT (e.g., poor cooperation or severe medical condition)
Refusal to consent to study procedures
Trial population
Adults aged 19 years or older with clinically diagnosed asthma or COPD who are receiving routine care at participating centers and consent to participate in a prospective observational cohort study involving clinical assessments, pulmonary function testing, and chest CT imaging.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: Prospective Asthma-COPD Cohort
Trial outcomes
Primary outcomes
1
Imaging and multi-omic signatures that differentiate asthma from COPD and predict treatment response
Composite signatures derived from quantitative chest CT metrics (e.g., low attenuation area percentage, parametric response mapping features, airway measurements, and mucus plug score) integrated with clinical variables, pulmonary function indices, blood-based inflammatory markers, and sputum/microbiome profiles. These integrated features will be evaluated for their ability to (1) distinguish asthma from COPD and (2) predict clinical treatment response.
Time frame
From baseline to last follow-up visit (anticipated up to 12 months after enrollment)Secondary outcomes
1
Change in Lung Function (FEV1)
Change in pre-bronchodilator and/or post-bronchodilator FEV1 (mL) from baseline to last follow-up visit.
Time frame
Baseline to 12 months2
Frequency of acute exacerbations
Number of moderate or severe exacerbations during follow-up.
Time frame
Up to 12 months after enrollment3
Changes in Quantitative Chest CT Imaging Biomarkers (LAA-950, PRMfSAD, Pi10, BV5/TBV)
Changes in chest CT-derived quantitative imaging biomarkers including parametric response mapping of functional low attenuation area at -950 HU (LAA-950), small airway disease (PRMfSAD), airway wall thickness (Pi10), and small vessel fraction (BV5/TBV) from baseline to last follow-up visit.
Time frame
Baseline to last follow-up visit (up to 12 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Korea University Guro Hospital
Lead sponsor
The Korean Academy of Tuberculosis and Respiratory Diseases
Collaborator
Seoul National University Boramae Hospital
Collaborator
Source ClinicalTrials.gov