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RecruitingNCT07602192CTOMICSUpdated Jul 7, 2026

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

An observational study in Asthma (Diagnosis) and COPD (Chronic Obstructive Pulmonary Disease), sponsored by Korea University Guro Hospital. Recruiting at 2 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by Korea University Guro Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
19 Years and older
Sex
All
01

Study 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.

Read the detailed description

This is a prospective, observational, multi-center cohort study designed to integrate quantitative chest CT imaging with multi-omics data to improve differentiation between asthma and chronic obstructive pulmonary disease (COPD) and to identify biomarkers associated with treatment response.

Eligible participants will include adults diagnosed with asthma or COPD who agree to participate in longitudinal clinical follow-up. At baseline and during follow-up, participants will undergo standard clinical assessments, including symptom questionnaires, pulmonary function testing, blood sampling, and chest CT imaging. Additional biological samples, such as sputum and microbiome specimens, may be collected when clinically feasible.

Quantitative CT metrics (e.g., low attenuation area percentage, parametric response mapping features, airway wall measurements, and mucus plug scores) will be extracted from imaging data. These imaging biomarkers will be integrated with clinical variables, laboratory parameters (including inflammatory markers and immunoglobulin profiles), and microbiome data.

The primary objectives are: (1) to identify imaging and biological signatures that distinguish asthma from COPD, and (2) to determine whether these signatures can predict response to standard clinical treatments. No investigational drugs or medical devices are involved, and all procedures reflect routine clinical care.

Data will be analyzed using advanced statistical and computational methods to explore associations between imaging, biological markers, and clinical outcomes. Results are expected to enhance understanding of disease mechanisms and support the development of personalized treatment strategies for chronic airway diseases.

02

Conditions studied

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

Keywords

  • Quantitative chest CT
  • Airway disease
  • Asthma
  • Chronic Obstructive Pulmonary Disease
  • Treatment response
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

05

What researchers measure

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 months

  2. Frequency of acute exacerbations

    Number of moderate or severe exacerbations during follow-up.

    Time frame: Up to 12 months after enrollment

  3. 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)

06

Study locations

2 of 2 sites recruiting
  • SMG-SNU Boramae Medical Center
    Seoul, Dongjak-gu 07061, South Korea
    Recruiting
  • Korea University Guro Hospital
    Seoul, Guro-gu 08308, South Korea
    Recruiting
07

References and documents

Publications

  • 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. PubMed 40742322 ↗
  • 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. PubMed 28065276 ↗
  • 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. PubMed 28848871 ↗
  • 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. PubMed 41633329 ↗

Individual participant data

Plan to share: Yes — De-identified individual participant data (IPD), including clinical variables, pulmonary function data, and quantitative chest CT metrics, may be shared with qualified investigators upon reasonable request. Data sharing will be subject to approval by the Institutional Review Board and execution of a data use agreement to ensure appropriate use, confidentiality, and protection of participant privacy. Requests may be submitted after publication of primary study results.

08

Registry details

Key details

Study ID
NCT07602192
Lead sponsor
Korea University Guro Hospital
Collaborators
The Korean Academy of Tuberculosis and Respiratory Diseases, Seoul National University Boramae Hospital
Responsible party
Kim, Sang Hyuk (Clinical Assistant Professor, Korea University Guro Hospital) — Principal investigator
First posted
May 22, 2026
Start date
Dec 22, 2025
Primary completion
Nov 30, 2027 (estimated)
Completion
Dec 22, 2027 (estimated)
Last update
Jul 7, 2026

Study contacts

Sang Hyuk Kim, MD
Contact
gost702@korea.ac.kr
+82-2-2626-1659
Clinical Research Office Korea University Guro Hospital
Contact
kumc.guro.rst@kumc.or.kr
+82-2-2626-1659
Sang Hyuk Kim, MD
principal investigator · Korea University Guro Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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