Chronic Obstructive Pulmonary Disease (COPD)NCT07873489
Multi-Omics Study of COPD Stages and Traditional Chinese Medicine Syndromes
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Traditional Chinese Medicine Syndrome, run by Guangzhou Institute of Respiratory Disease.
Trial summary
This is a multicenter, prospective, observational cohort study of patients with chronic obstructive pulmonary disease (COPD), individuals with pre-COPD, and healthy participants. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Traditional Chinese Medicine Syndrome, Multi-omics
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
- Healthy control participants: age 35 years or older, without COPD based on symptoms, pulmonary function, and chest imaging criteria defined in the protocol.
- Participants in COPD-related groups must have traditional Chinese medicine syndrome assessment information available according to the study protocol.
Who cannot join
- 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.
- Pregnancy or lactation, where applicable according to participant group.
- Participation in another clinical study that may interfere with this study.
- Any other condition judged by the investigator to make the participant unsuitable for this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Multi-Omics Characterization of Patients With Chronic Obstructive Pulmonary Disease Across Disease Stages and Traditional Chinese Medicine Syndromes
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.
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Traditional Chinese Medicine Syndrome, Multi-omics
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pre-COPD | 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. | |
| Stable COPD GOLD 1-2 | Participants with stable chronic obstructive pulmonary disease classified as GOLD stage 1 or 2. | |
| Stable COPD GOLD 3-4 | Participants with stable chronic obstructive pulmonary disease classified as GOLD stage 3 or 4. | |
| Acute Exacerbation of COPD | Participants with acute exacerbation of chronic obstructive pulmonary disease, with follow-up after remission according to the study protocol. | |
| Healthy Controls | Healthy participants without COPD, including smokers and non-smokers, enrolled as controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (19)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuqiong Yang, Guangzhou Institute of Respiratory Disease
- Investigators
- Yuqiong Yang, PhD, Principal investigator, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873489
- Sponsor's protocol ID
- 2026ZD0555401
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Omics Characterization of Patients With Chronic Obstructive Pulmonary Disease Across Disease Stages and Traditional Chinese Medicine Syndromes
- ClinicalTrials.gov ID
- NCT07873489
- Acronym / sponsor ID
- 2026ZD0555401
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Traditional Chinese Medicine Syndrome, Multi-omics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 14 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pre-COPD | – | –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. |
| Stable COPD GOLD 1-2 | – | –Participants with stable chronic obstructive pulmonary disease classified as GOLD stage 1 or 2. |
| Stable COPD GOLD 3-4 | – | –Participants with stable chronic obstructive pulmonary disease classified as GOLD stage 3 or 4. |
| Acute Exacerbation of COPD | – | –Participants with acute exacerbation of chronic obstructive pulmonary disease, with follow-up after remission according to the study protocol. |
| Healthy Controls | – | –Healthy participants without COPD, including smokers and non-smokers, enrolled as controls. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
- Healthy control participants: age 35 years or older, without COPD based on symptoms, pulmonary function, and chest imaging criteria defined in the protocol.
Key exclusion criteria (7 listed)
- 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.
- Pregnancy or lactation, where applicable according to participant group.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Differentially Abundant Microbial Species in Sputum at Baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Number of Differentially Expressed Genes in Peripheral Blood at Baseline
Time frame: 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.
Number of Cell Type-Specific Differentially Expressed Genes at Baseline
Time frame: 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.
Number of Differentially Abundant Blood Proteins at Baseline
Time frame: 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.
Number of Significant Microbe-Metabolite-Host Immune Network Associations at Baseline
Time frame: 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.
Number of Molecular Network Modules Associated With COPD Stage or Traditional Chinese Medicine Syndrome at Baseline
Time frame: 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.
Macro-Averaged Area Under the Receiver Operating Characteristic Curve of the Stage-Syndrome-Molecular Classification Model
Time frame: Baseline
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.
19 secondary outcomes
Annualized COPD Exacerbation Rate
Time frame: From enrollment through Month 24
Time to First COPD Exacerbation
Time frame: From enrollment through Month 24
Forced Expiratory Volume in 1 Second
Time frame: Baseline, Month 12, and Month 24
Change From Baseline in FEV1 Percent Predicted at Month 12
Time frame: Baseline and Month 12
Change From Baseline in FEV1 Percent Predicted at Month 24
Time frame: Baseline and Month 24
Post-Bronchodilator FEV1/FVC Ratio
Time frame: Baseline, Month 12, and Month 24
Diffusing Capacity of the Lung for Carbon Monoxide Percent Predicted
Time frame: Baseline, Month 12, and Month 24
COPD Assessment Test Total Score
Time frame: Baseline, Month 6, Month 12, and Month 24
Modified Medical Research Council Dyspnea Scale Grade
Time frame: Baseline, Month 6, Month 12, and Month 24
Blood Neutrophil Percentage at Baseline
Time frame: Baseline
Blood Eosinophil Percentage at Baseline
Time frame: Baseline
Blood Lymphocyte Percentage at Baseline
Time frame: Baseline
High-Sensitivity C-Reactive Protein Concentration at Baseline
Time frame: Baseline
D-Dimer Concentration at Baseline
Time frame: Baseline
Fractional Exhaled Nitric Oxide at Baseline
Time frame: Baseline
Change From Baseline in Airway Wall Area Percentage at Month 24
Time frame: Baseline and Month 24
Change From Baseline in Emphysema Percentage at Month 24
Time frame: Baseline and Month 24
Change From Baseline in Air Trapping Percentage at Month 24
Time frame: Baseline and Month 24
Distribution of Traditional Chinese Medicine Syndrome Classifications
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuqiong Yang, PhD principal investigator
Guangzhou Institute of Respiratory Disease
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Traditional Chinese Medicine Syndrome, run by Guangzhou Institute of Respiratory Disease.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuqiong Yang, PhD (+86 15622136450, yangyuqiongcoma@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Differentially Abundant Microbial Species in Sputum at Baseline (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.