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

3 juli 2026 bijgewerkt door: Kim, Sang Hyuk, Korea University Guro Hospital

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.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

200

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

  • Naam: Clinical Research Office Korea University Guro Hospital
  • Telefoonnummer: +82-2-2626-1659
  • E-mail: kumc.guro.rst@kumc.or.kr

Studie Locaties

  • Zuid -Korea
    • Dongjak-gu
      • Seoul, Dongjak-gu, Zuid -Korea, 07061
        • Werving
        • SMG-SNU Boramae Medical Center
        • Contact:
    • Guro-gu
      • Seoul, Guro-gu, Zuid -Korea, 08308
        • Werving
        • Korea University Guro Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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:

  • 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Imaging and multi-omic signatures that differentiate asthma from COPD and predict treatment response
Tijdsspanne: 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.
From baseline to last follow-up visit (anticipated up to 12 months after enrollment)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Lung Function (FEV1)
Tijdsspanne: Baseline to 12 months
Change in pre-bronchodilator and/or post-bronchodilator FEV1 (mL) from baseline to last follow-up visit.
Baseline to 12 months
Frequency of acute exacerbations
Tijdsspanne: Up to 12 months after enrollment
Number of moderate or severe exacerbations during follow-up.
Up to 12 months after enrollment
Changes in Quantitative Chest CT Imaging Biomarkers (LAA-950, PRMfSAD, Pi10, BV5/TBV)
Tijdsspanne: Baseline to last follow-up visit (up to 12 months)
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.
Baseline to last follow-up visit (up to 12 months)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Korea University Guro Hospital

Medewerkers

Seoul National University Boramae Hospital
The Korean Academy of Tuberculosis and Respiratory Diseases

Onderzoekers

  • Hoofdonderzoeker: Sang Hyuk Kim, MD, Korea University Guro Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

22 december 2025

Primaire voltooiing (Geschat)

30 november 2027

Studie voltooiing (Geschat)

22 december 2027

Studieregistratiedata

Eerst ingediend

22 februari 2026

Eerst ingediend dat voldeed aan de QC-criteria

20 mei 2026

Eerst geplaatst (Werkelijk)

22 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

3 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CTOMICS1
  • 2025GR0637 (Andere identificatie: Korea University Guro Hospital IRB)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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