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

Официальное название

Prospective Multicenter Cohort to Discriminate Asthma Versus Chronic Obstructive Pulmonary Disease and Predict Treatment Response Using Quantitative Chest CT and Multi-Omics

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Imaging and multi-omic signatures that differentiate asthma from COPD and predict treatment response [Срок оценки: From baseline to last follow-up visit (anticipated up to 12 months after enrollment)]

Вторичные конечные точки (3)

• Change in Lung Function (FEV1) [Срок оценки: Baseline to 12 months]
• Frequency of acute exacerbations [Срок оценки: Up to 12 months after enrollment]
• Changes in Quantitative Chest CT Imaging Biomarkers (LAA-950, PRMfSAD, Pi10, BV5/TBV) [Срок оценки: Baseline to last follow-up visit (up to 12 months)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 2 центра

• SMG-SNU Boramae Medical Center — Seoul
• Korea University Guro Hospital — Seoul

Публикации

• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07602192 · CTOMICS1 · 2025GR0637

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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