[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100660161":3},{"organization":4,"outcomesModule":7,"designInfo":104,"detailedDescription":103,"studyPopulation":107,"armGroups":108,"interventions":103,"overallOfficials":124,"centralContacts":128,"locations":103,"responsibleParty":133,"collaborators":103,"id":136,"slug":137,"hasResults":138,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":103,"eligibilityCriteria":142,"healthyVolunteers":143,"sex":144,"minAge":145,"maxAge":103,"enrollmentInfo":146,"targetDuration":103,"studyType":149,"phases":103,"briefSummary":150,"conditions":151,"keywords":103,"overallStatus":155,"whyStopped":103,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":103},{"fullName":5,"class":6},"Guangzhou Institute of Respiratory Disease","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":40,"otherOutcomes":103},[9,13,16,19,22,25,28,31,34,37],{"measure":10,"description":11,"timeFrame":12},"Number of Differentially Abundant Microbial Species in Sputum at Baseline","Shotgun metagenomic sequencing will be performed on sputum samples. Differentially abundant microbial species across the prespecified COPD stage groups and traditional Chinese medicine syndrome groups will be identified using false discovery rate correction. This outcome is the total number of unique microbial species with a Benjamini-Hochberg false discovery rate-adjusted P value below 0.05 in either prespecified analysis; duplicate species will be counted once.","Baseline",{"measure":14,"description":15,"timeFrame":12},"Number of Differentially Abundant Microbial Species in Stool at Baseline","Shotgun metagenomic sequencing will be performed on stool samples. Differentially abundant microbial species across the prespecified COPD stage groups and traditional Chinese medicine syndrome groups will be identified using false discovery rate correction. This outcome is the total number of unique microbial species with a Benjamini-Hochberg false discovery rate-adjusted P value below 0.05 in either prespecified analysis; duplicate species will be counted once.",{"measure":17,"description":18,"timeFrame":12},"Number of Differentially Abundant Serum Metabolites at Baseline","Serum metabolomic profiling will be performed using liquid chromatography-mass spectrometry. This outcome is the total number of unique annotated serum metabolites differing across the prespecified COPD stage groups or traditional Chinese medicine syndrome groups with a Benjamini-Hochberg false discovery rate-adjusted P value below 0.05; duplicate metabolites will be counted once.",{"measure":20,"description":21,"timeFrame":12},"Number of Differentially Abundant Stool Metabolites at Baseline","Stool metabolomic profiling will be performed using liquid chromatography-mass spectrometry. This outcome is the total number of unique annotated stool metabolites differing across the prespecified COPD stage groups or traditional Chinese medicine syndrome groups with a Benjamini-Hochberg false discovery rate-adjusted P value below 0.05; duplicate metabolites will be counted once.",{"measure":23,"description":24,"timeFrame":12},"Number of Differentially Expressed Genes in Peripheral Blood at Baseline","Bulk RNA sequencing will be performed using peripheral blood samples. This outcome is the total number of unique genes differentially expressed across the prespecified COPD stage groups or traditional Chinese medicine syndrome groups with a Benjamini-Hochberg false discovery rate-adjusted P value below 0.05; duplicate genes will be counted once.",{"measure":26,"description":27,"timeFrame":12},"Number of Cell Type-Specific Differentially Expressed Genes at Baseline","Single-cell RNA sequencing will be performed using peripheral blood mononuclear cells. Differential expression analysis will be conducted separately within each annotated cell type. This outcome is the total number of unique genes with a Benjamini-Hochberg false discovery rate-adjusted P value below 0.05 across the prespecified COPD stage or traditional Chinese medicine syndrome comparisons; genes identified in more than one cell type will be counted once.",{"measure":29,"description":30,"timeFrame":12},"Number of Differentially Abundant Blood Proteins at Baseline","Blood proteomic profiling will be performed using mass spectrometry-based methods. This outcome is the total number of unique proteins differing across the prespecified COPD stage groups or traditional Chinese medicine syndrome groups with a Benjamini-Hochberg false discovery rate-adjusted P value below 0.05; duplicate proteins will be counted once.",{"measure":32,"description":33,"timeFrame":12},"Number of Significant Microbe-Metabolite-Host Immune Network Associations at Baseline","Associations among microbial, metabolite, and host immune features will be evaluated after adjustment for age, sex, body mass index, and smoking exposure. This outcome is the total number of network edges with a Benjamini-Hochberg false discovery rate-adjusted P value below 0.05.",{"measure":35,"description":36,"timeFrame":12},"Number of Molecular Network Modules Associated With COPD Stage or Traditional Chinese Medicine Syndrome at Baseline","Multi-omics network modules will be identified using weighted network analysis. Module eigengenes will be tested for association with COPD stage and traditional Chinese medicine syndrome category after adjustment for age, sex, body mass index, and smoking exposure. This outcome is the total number of unique modules with a Benjamini-Hochberg false discovery rate-adjusted P value below 0.05; modules associated with both variables will be counted once.",{"measure":38,"description":39,"timeFrame":12},"Macro-Averaged Area Under the Receiver Operating Characteristic Curve of the Stage-Syndrome-Molecular Classification Model","A multi-class classification model will be developed using baseline clinical and multi-omics features to classify participants according to the prespecified COPD stage and traditional Chinese medicine syndrome categories. Discrimination will be evaluated using the macro-averaged one-vs-rest area under the receiver operating characteristic curve based on cross-validated predictions. Values range from 0 to 1, with higher values indicating better discrimination.",[41,45,48,52,56,60,63,66,70,73,76,79,82,85,88,91,94,97,100],{"measure":42,"description":43,"timeFrame":44},"Annualized COPD Exacerbation Rate","The number of COPD exacerbations during follow-up will be divided by the participant's observed follow-up time in years and reported as exacerbations per person-year.","From enrollment through Month 24",{"measure":46,"description":47,"timeFrame":44},"Time to First COPD Exacerbation","Time from enrollment to the first protocol-defined COPD exacerbation will be reported in days. Participants without an exacerbation will be censored at the date of their last completed follow-up.",{"measure":49,"description":50,"timeFrame":51},"Forced Expiratory Volume in 1 Second","Post-bronchodilator forced expiratory volume in 1 second will be measured by spirometry and reported in liters.","Baseline, Month 12, and Month 24",{"measure":53,"description":54,"timeFrame":55},"Change From Baseline in FEV1 Percent Predicted at Month 12","The absolute change in post-bronchodilator forced expiratory volume in 1 second percent predicted will be calculated as the Month 12 value minus the baseline value and reported in percentage points.","Baseline and Month 12",{"measure":57,"description":58,"timeFrame":59},"Change From Baseline in FEV1 Percent Predicted at Month 24","The absolute change in post-bronchodilator forced expiratory volume in 1 second percent predicted will be calculated as the Month 24 value minus the baseline value and reported in percentage points.","Baseline and Month 24",{"measure":61,"description":62,"timeFrame":51},"Post-Bronchodilator FEV1\u002FFVC Ratio","The ratio of post-bronchodilator forced expiratory volume in 1 second to forced vital capacity will be measured by spirometry and reported as a percentage.",{"measure":64,"description":65,"timeFrame":51},"Diffusing Capacity of the Lung for Carbon Monoxide Percent Predicted","Diffusing capacity of the lung for carbon monoxide will be measured according to standardized pulmonary function procedures and reported as percent predicted.",{"measure":67,"description":68,"timeFrame":69},"COPD Assessment Test Total Score","Respiratory health status will be assessed using the Chronic Obstructive Pulmonary Disease Assessment Test. The test consists of 8 items, each scored from 0 to 5, producing a total score ranging from 0 to 40. Higher scores indicate a greater adverse impact of COPD on health status.","Baseline, Month 6, Month 12, and Month 24",{"measure":71,"description":72,"timeFrame":69},"Modified Medical Research Council Dyspnea Scale Grade","Dyspnea-related functional limitation will be assessed using the modified Medical Research Council Dyspnea Scale. Grades range from 0 to 4, with higher grades indicating more severe dyspnea-related activity limitation.",{"measure":74,"description":75,"timeFrame":12},"Blood Neutrophil Percentage at Baseline","The percentage of neutrophils among circulating white blood cells will be measured using an automated hematology analyzer and reported as a percentage.",{"measure":77,"description":78,"timeFrame":12},"Blood Eosinophil Percentage at Baseline","The percentage of eosinophils among circulating white blood cells will be measured using an automated hematology analyzer and reported as a percentage.",{"measure":80,"description":81,"timeFrame":12},"Blood Lymphocyte Percentage at Baseline","The percentage of lymphocytes among circulating white blood cells will be measured using an automated hematology analyzer and reported as a percentage.",{"measure":83,"description":84,"timeFrame":12},"High-Sensitivity C-Reactive Protein Concentration at Baseline","Serum high-sensitivity C-reactive protein concentration will be measured using the study laboratory assay and reported in milligrams per liter.",{"measure":86,"description":87,"timeFrame":12},"D-Dimer Concentration at Baseline","Plasma D-dimer concentration will be measured using the study laboratory assay and reported in milligrams per liter fibrinogen equivalent units.",{"measure":89,"description":90,"timeFrame":12},"Fractional Exhaled Nitric Oxide at Baseline","Fractional exhaled nitric oxide will be measured using a standardized exhaled nitric oxide analyzer and reported in parts per billion.",{"measure":92,"description":93,"timeFrame":59},"Change From Baseline in Airway Wall Area Percentage at Month 24","Airway wall area percentage will be calculated for segmental bronchi on quantitative chest computed tomography as airway wall area divided by total airway area multiplied by 100. Change will be calculated as the Month 24 value minus the baseline value and reported in percentage points.",{"measure":95,"description":96,"timeFrame":59},"Change From Baseline in Emphysema Percentage at Month 24","Emphysema percentage will be calculated on inspiratory chest computed tomography as the percentage of total lung voxels with attenuation below -950 Hounsfield units. Change will be calculated as the Month 24 value minus the baseline value and reported in percentage points.",{"measure":98,"description":99,"timeFrame":59},"Change From Baseline in Air Trapping Percentage at Month 24","Air trapping percentage will be calculated on expiratory chest computed tomography as the percentage of total lung voxels with attenuation below -856 Hounsfield units. Change will be calculated as the Month 24 value minus the baseline value and reported in percentage points.",{"measure":101,"description":102,"timeFrame":12},"Distribution of Traditional Chinese Medicine Syndrome Classifications","Participants with COPD will be classified according to the Diagnostic Criteria for Traditional Chinese Medicine Syndromes of Chronic Obstructive Pulmonary Disease (2011 edition), using standardized inspection, listening and smelling, inquiry, and palpation information. The stable COPD categories are lung qi deficiency, lung-spleen qi deficiency, lung-kidney qi deficiency, and lung-kidney qi-yin deficiency. The acute exacerbation categories are phlegm-heat obstructing the lung and phlegm-turbidity obstructing the lung. Results will be reported as the number and percentage of participants in each category.",null,{"allocation":103,"interventionModel":103,"interventionModelDescription":103,"primaryPurpose":103,"observationalModel":105,"timePerspective":106,"maskingInfo":103},"COHORT","PROSPECTIVE","The study population will include adults with pre-COPD, stable COPD at different GOLD stages, acute exacerbation of COPD, and healthy controls recruited from the participating clinical center or centers.",[109,112,115,118,121],{"label":110,"type":103,"description":111,"interventionNames":103},"Pre-COPD","Participants with pre-COPD who have risk factors and\u002For early clinical, pulmonary function, or imaging features but do not meet spirometric criteria for COPD.",{"label":113,"type":103,"description":114,"interventionNames":103},"Stable COPD GOLD 1-2","Participants with stable chronic obstructive pulmonary disease classified as GOLD stage 1 or 2.",{"label":116,"type":103,"description":117,"interventionNames":103},"Stable COPD GOLD 3-4","Participants with stable chronic obstructive pulmonary disease classified as GOLD stage 3 or 4.",{"label":119,"type":103,"description":120,"interventionNames":103},"Acute Exacerbation of COPD","Participants with acute exacerbation of chronic obstructive pulmonary disease, with follow-up after remission according to the study protocol.",{"label":122,"type":103,"description":123,"interventionNames":103},"Healthy Controls","Healthy participants without COPD, including smokers and non-smokers, enrolled as controls.",[125],{"name":126,"affiliation":5,"role":127},"Yuqiong Yang, PhD","PRINCIPAL_INVESTIGATOR",[129],{"name":126,"role":130,"phone":131,"phoneExt":103,"email":132},"CONTACT","+86 15622136450","yangyuqiongcoma@163.com",{"type":127,"investigatorFullName":134,"investigatorTitle":135,"investigatorAffiliation":5,"oldNameTitle":103,"oldOrganization":103},"Yuqiong Yang","Principal Investigator","100660161","multi-omics-study-of-copd-stages-and-traditional-chinese-medicine-syndromes-100660161",false,"NCT07873489","Multi-Omics Study of COPD Stages and Traditional Chinese Medicine Syndromes","Multi-Omics Characterization of Patients With Chronic Obstructive Pulmonary Disease Across Disease Stages and Traditional Chinese Medicine Syndromes","Inclusion Criteria:\n\n* Able and willing to provide written informed consent and complete study assessments and follow-up.\n* Pre-COPD participants: age 35 years or older, without spirometric airflow obstruction, and with COPD risk factors and\u002For early clinical, pulmonary function, or imaging features according to the study protocol.\n* Stable COPD participants: age 40 years or older, with a diagnosis of COPD based on post-bronchodilator FEV1\u002FFVC \\\u003C 0.70, in stable condition without acute exacerbation within the specified period before enrollment, and classified as GOLD stage 1-2 or GOLD stage 3-4.\n* Acute exacerbation of COPD participants: age 40 years or older, with COPD based on post-bronchodilator FEV1\u002FFVC \\\u003C 0.70 and an acute exacerbation meeting protocol-defined criteria, enrolled within the protocol-defined time window.\n* Healthy control participants: age 35 years or older, without COPD based on symptoms, pulmonary function, and chest imaging criteria defined in the protocol.\n* Participants in COPD-related groups must have traditional Chinese medicine syndrome assessment information available according to the study protocol.\n\nExclusion Criteria:\n\n* Unable or unwilling to provide informed consent or comply with study procedures and follow-up.\n* Respiratory diseases or other conditions that may substantially interfere with COPD-related assessments, including protocol-defined asthma, severe bronchiectasis, active pulmonary tuberculosis, lung cancer, interstitial lung disease, or other major pulmonary diseases.\n* Severe cardiovascular, hepatic, renal, hematologic, neurologic, psychiatric, malignant, immune, or infectious diseases that, in the investigator's judgment, make participation inappropriate or may affect study assessments.\n* Recent systemic glucocorticoid or antibiotic use, or other protocol-defined medication exposures, that may affect study-related sample collection or assessment.\n* Pregnancy or lactation, where applicable according to participant group.\n* Participation in another clinical study that may interfere with this study.\n* Any other condition judged by the investigator to make the participant unsuitable for this study.",true,"ALL","35 Years",{"count":147,"type":148},400,"ESTIMATED","OBSERVATIONAL","This is a multicenter, prospective, observational cohort study of patients with chronic obstructive pulmonary disease (COPD), individuals with pre-COPD, and healthy participants. The study will enroll approximately 400 participants, including individuals with pre-COPD, patients with stable COPD at different GOLD stages, patients with acute exacerbation of COPD, and healthy controls.\n\nParticipants will not be assigned to any study intervention. Clinical information, pulmonary function, imaging information, traditional Chinese medicine syndrome assessment, and biological samples will be collected according to the study protocol. Multi-omics analyses, including metagenomics, metabolomics, transcriptomics, and proteomics, will be used to characterize molecular features associated with COPD stages and traditional Chinese medicine syndromes. Participants will be followed to evaluate clinical characteristics, exacerbations, pulmonary function changes, and multi-omics features over time.",[152,153,154],"Chronic Obstructive Pulmonary Disease (COPD)","Traditional Chinese Medicine Syndrome","Multi-omics","NOT_YET_RECRUITING","2026-10-07",{"date":158,"type":159},"2026-10-14","ACTUAL",{"date":161,"type":148},"2026-10-01",{"date":163,"type":148},"2030-04-30",{"name":5,"class":6}]