Quantitative Chest CT and Multi-Omics to Distinguish Asthma From COPD and Predict Treatment Response

NCT07602192 | Recruiting

• 2 other identifiers: CTOMICS12025GR0637
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma (Diagnosis); COPD (Chronic Obstructive Pulmonary Disease)

Keywords

Quantitative chest CT; Airway disease; Asthma; Chronic Obstructive Pulmonary Disease; Treatment response

Outcome Measures

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.

  From baseline to last follow-up visit (anticipated up to 12 months after enrollment)

Secondary Outcomes (3)

• Change in Lung Function (FEV1)

  Baseline to 12 months

• Frequency of acute exacerbations

  Up to 12 months after enrollment

• Changes in Quantitative Chest CT Imaging Biomarkers (LAA-950, PRMfSAD, Pi10, BV5/TBV)

  Baseline to last follow-up visit (up to 12 months)

Study Arms (1)

Prospective Asthma-COPD Cohort

This cohort includes adults with physician-diagnosed asthma or chronic obstructive pulmonary disease (COPD) who are enrolled in a prospective, observational study. Participants undergo routine clinical assessments, pulmonary function testing, blood sampling, and chest computed tomography (CT) imaging as part of standard care and study-related data collection. No investigational drugs or medical devices are administered. Data from clinical evaluations, imaging, and biospecimens (e.g., blood and sputum) will be analyzed to characterize disease features and predict treatment response.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Guro Hospital: lead
• The Korean Academy of Tuberculosis and Respiratory Diseases: collaborator

Study Sites (1)

Korea University Guro Hospital

Seoul, Guro-gu, 08308, South Korea

RECRUITING

Related Publications (4)

• Chaudhary MFA, Bhatt SP. Imaging Endpoints for Biologic Therapy in Chronic Obstructive Pulmonary Disease. Br J Radiol. 2025 Jul 31:tqaf179. doi: 10.1093/bjr/tqaf179. Online ahead of print.

  PMID: 40742322 BACKGROUND

• Trivedi A, Hall C, Hoffman EA, Woods JC, Gierada DS, Castro M. Using imaging as a biomarker for asthma. J Allergy Clin Immunol. 2017 Jan;139(1):1-10. doi: 10.1016/j.jaci.2016.11.009.

  PMID: 28065276 BACKGROUND

• Bhatt SP, Han MK. Developing and Implementing Biomarkers and Novel Imaging in COPD. Chronic Obstr Pulm Dis. 2016 Jan 15;3(1):485-490. doi: 10.15326/jcopdf.3.1.2015.0170.

  PMID: 28848871 BACKGROUND

• Kim SH, Yang Z, Chang SW, Sim JK, Oh JY, Min KH, Hur GY, Lee SY, Shim JJ, Choi J, Yong HS. Airway Quantification Using Ultra-Low-Dose Computed Tomography Correlates With Pulmonary Function Indices in Patients With Asthma. J Korean Med Sci. 2026 Feb 2;41(5):e56. doi: 10.3346/jkms.2026.41.e56.

  PMID: 41633329 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples, sputum samples, and routine clinical laboratory specimens collected as part of standard care.

MeSH Terms

Conditions

Asthma; Disease; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes

Study Officials

• Sang Hyuk Kim, MD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Hyuk Kim, MD

CONTACT

+82-2-2626-1659; gost702@korea.ac.kr

Clinical Research Office Korea University Guro Hospital

CONTACT

+82-2-2626-1659; kumc.guro.rst@kumc.or.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: May 22, 2026
• Study Start: December 22, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 22, 2027
• Last Updated: May 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)