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.
Able and willing to provide written informed consent and complete study assessments and follow-up.
Pre-COPD participants: age 35 years or older, without spirometric airflow obstruction, and with COPD risk factors and/or early clinical, pulmonary function, or imaging features according to the study protocol.
Stable COPD participants: age 40 years or older, with a diagnosis of COPD based on post-bronchodilator FEV1/FVC < 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.
Acute exacerbation of COPD participants: age 40 years or older, with COPD based on post-bronchodilator FEV1/FVC < 0.70 and an acute exacerbation meeting protocol-defined criteria, enrolled within the protocol-defined time window.
Unable or unwilling to provide informed consent or comply with study procedures and follow-up.
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.
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.
Recent systemic glucocorticoid or antibiotic use, or other protocol-defined medication exposures, that may affect study-related sample collection or assessment.
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.
Cohort
Prospective
Not listed
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.
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.
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.
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.
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 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.
Forced Expiratory Volume in 1 Second
Post-bronchodilator forced expiratory volume in 1 second will be measured by spirometry and reported in liters.
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.
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