Asthma (Diagnosis)CTOMICSNCT07602192
Quantitative Chest CT and Multi-Omics to Distinguish Asthma From COPD and Predict Treatment Response
An observational study of Asthma (Diagnosis) and COPD (Chronic Obstructive Pulmonary Disease), run by Korea University Guro Hospital at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Asthma (Diagnosis), COPD (Chronic Obstructive Pulmonary Disease)
- How many people
- 200 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 22 Dec 2025to 22 Dec 2027
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Research Office Korea University Guro Hospital contact
South Korea2 sites, 2 recruiting
- Recruiting
SMG-SNU Boramae Medical Center
Seoul, Dongjak-gu, 07061
Hyun Woo Lee, MD, PhD, 82-2-870-3432, athrunzara86@snu.ac.kr
- Recruiting
Korea University Guro Hospital
Seoul, Guro-gu, 08308
Sang Hyuk Kim, MD, 82-2-2626-3192, gost702@korea.ac.kr
About this study
Official title: Prospective Multicenter Cohort to Discriminate Asthma Versus Chronic Obstructive Pulmonary Disease and Predict Treatment Response Using Quantitative Chest CT and Multi-Omics
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.
- Keywords
- Quantitative chest CT, Airway disease, Asthma, Chronic Obstructive Pulmonary Disease, Treatment response
- Medical subject headings
- Asthma, Disease, Pulmonary Disease, Chronic Obstructive
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 |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to last follow-up visit (anticipated up to 12 months after enrollment)
Secondary outcomes (3)
Change in Lung Function (FEV1)
Change in pre-bronchodilator and/or post-bronchodilator FEV1 (mL) from baseline to last follow-up visit.
Measured: Baseline to 12 months
Frequency of acute exacerbations
Number of moderate or severe exacerbations during follow-up.
Measured: Up to 12 months after enrollment
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.
Measured: Baseline to last follow-up visit (up to 12 months)
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 start22 Dec 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion22 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Asthma (Diagnosis)Studies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Korean Academy of Tuberculosis and Respiratory Diseases, Seoul National University Boramae Hospital
- Responsible party
- Principal investigator, Kim, Sang Hyuk, Korea University Guro Hospital
- Investigators
- Sang Hyuk Kim, MD, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602192
- Sponsor's protocol ID
- CTOMICS1
- Other IDs
- 2025GR0637
- Acronym
- CTOMICS
- Status last verified
- Jul 2026
- First submitted
- 22 Feb 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Chaudhary MFA, Bhatt SP. Imaging endpoints for biologic therapy in chronic obstructive pulmonary disease. Br J Radiol. 2026 Aug 1;99(1184):1474-1477. doi: 10.1093/bjr/tqaf179.
PubMed 40742322Trivedi 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 28065276Bhatt 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 28848871Kim 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Cohort to Discriminate Asthma Versus Chronic Obstructive Pulmonary Disease and Predict Treatment Response Using Quantitative Chest CT and Multi-Omics
- ClinicalTrials.gov ID
- NCT07602192
- Acronym / sponsor ID
- CTOMICS / CTOMICS1
- Keywords
- Quantitative chest CT, Airway disease, Asthma, Chronic Obstructive Pulmonary Disease, Treatment response
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Collaborators
- The Korean Academy of Tuberculosis and Respiratory Diseases, Seoul National University Boramae Hospital
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 22 Dec 2027 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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
Imaging and multi-omic signatures that differentiate asthma from COPD and predict treatment response
Time frame: From baseline to last follow-up visit (anticipated up to 12 months after enrollment)
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.
3 secondary outcomes
Change in Lung Function (FEV1)
Time frame: Baseline to 12 months
Frequency of acute exacerbations
Time frame: Up to 12 months after enrollment
Changes in Quantitative Chest CT Imaging Biomarkers (LAA-950, PRMfSAD, Pi10, BV5/TBV)
Time frame: Baseline to last follow-up visit (up to 12 months)
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 7 Jul 2026.
- Background: PubMed 40742322Chaudhary MFA, Bhatt SP. Imaging endpoints for biologic therapy in chronic obstructive pulmonary disease. Br J Radiol. 2026 Aug 1;99(1184):1474-1477. doi: 10.1093/bjr/tqaf179.
- Background: PubMed 28065276Trivedi 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.
- Background: PubMed 28848871Bhatt 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.
- Background: PubMed 41633329Kim 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.
- Individual participant dataSharing planned: 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.
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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.
Clinical Research Office Korea University Guro Hospital contact
Sang Hyuk Kim, MD principal investigator
Korea University Guro Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma (Diagnosis) and COPD (Chronic Obstructive Pulmonary Disease), run by Korea University Guro Hospital at 2 sites in South Korea.
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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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 Sang Hyuk Kim, MD (+82-2-2626-1659, gost702@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging and multi-omic signatures that differentiate asthma from COPD and predict treatment response (time frame: From baseline to last follow-up visit (anticipated up to 12 months after enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07602192, which also lists 4 linked publications.
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 7 Jul 2026.