An observational study in Chronic Obstructive Pulmonary Disease (COPD), Traditional Chinese Medicine Syndrome and Multi-omics, sponsored by Guangzhou Institute of Respiratory Disease. Not yet recruiting. Open to participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Guangzhou Institute of Respiratory Disease · 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.
Participants 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.
4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's planned enrollment of 400 is above the median of 183 across 1,099 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Guangzhou Institute of Respiratory Disease is the lead sponsor of 99 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants with pre-COPD who have risk factors and/or early clinical, pulmonary function, or imaging features but do not meet spirometric criteria for COPD.
Participants with stable chronic obstructive pulmonary disease classified as GOLD stage 1 or 2.
Participants with stable chronic obstructive pulmonary disease classified as GOLD stage 3 or 4.
Participants with acute exacerbation of chronic obstructive pulmonary disease, with follow-up after remission according to the study protocol.
Healthy participants without COPD, including smokers and non-smokers, enrolled as controls.
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: From enrollment through Month 24
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.
Time frame: From enrollment through Month 24
Forced Expiratory Volume in 1 Second
Post-bronchodilator forced expiratory volume in 1 second will be measured by spirometry and reported in liters.
Time frame: Baseline, Month 12, and Month 24
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.
Time frame: Baseline and Month 12
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.
Time frame: Baseline and Month 24
Post-Bronchodilator FEV1/FVC 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.
Time frame: Baseline, Month 12, and Month 24
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.
Time frame: Baseline, Month 12, and Month 24
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.
Time frame: Baseline, Month 6, Month 12, and Month 24
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.
Time frame: Baseline, Month 6, Month 12, and Month 24
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline and Month 24
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.
Time frame: Baseline and Month 24
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.
Time frame: Baseline and Month 24
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.
Time frame: Baseline
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared outside the research team because the approved study protocol requires internal management of participant-level data with controlled access.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Apr 2030, 42 months later.
Of 330 non-industry observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 86. This study's planned 42 months is above that.
Counting every sponsor, half of 429 studies reached it within 28 months; a quarter within 16 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →
Guangzhou Institute of Respiratory Disease