Chronic Obstructive Pulmonary Disease (COPD)NCT07780682
TCM Cohort for Elderly COPD
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study evaluates the real-world clinical efficacy of traditional Chinese medicine (TCM) in elderly Chronic obstructive pulmonary disease (COPD) patients and explores syndrome characteristics and their associations with biomarkers. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Traditional Chinese medicine (TCM) and Non-traditional Chinese medicine (non-TCM)
- How many people
- 2,386 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2026to 28 Feb 2030
- How long will I take part?
- 52 Weeks
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: COPD is a common chronic respiratory disease characterized by persistent respiratory symptoms and airflow limitation, with recurrent acute exacerbations and progressive impairment of respiratory function.
Who may be able to join
- Patients diagnosed with COPD;
- Age ≥ 60 years old;
- Voluntary participation in this study, and sign the informed consent form.
Who cannot join
- Patients with various mental illnesses or other conditions that prevent normal communication;
- Patients with a history of pulmonary surgery, such as lung volume reduction surgery or lung transplantation;
- Patients with confirmed human immunodeficiency virus infection or acquired immunodeficiency syndrome.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jiansheng Li contact
China1 site
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, 450000
About this study
Official title: A Prospective Traditional Chinese Medicine Cohort Study of Chronic Obstructive Pulmonary Disease in the Elderly
This study evaluates the real-world clinical efficacy of traditional Chinese medicine (TCM) in elderly Chronic obstructive pulmonary disease (COPD) patients and explores syndrome characteristics and their associations with biomarkers.
Read the detailed description
This prospective cohort study, with TCM as the exposure, will enroll 2,386 elderly COPD patients for a 1-year follow-up. The primary evaluation uses the annual acute exacerbation rate as the outcome to evaluate the clinical efficacy of TCM. In addition, the study will investigate the characteristics of TCM syndromes.
Based on the cohort, we will collect peripheral blood, exhaled breath condensate, sputum, and tongue coating samples from 200 elderly COPD patients with four typical TCM syndromes, 200 non-elderly COPD patients with corresponding syndromes, and 50 healthy volunteers. Multi-omics approaches will be used to identify TCM syndrome-related biomarkers.
- Being tested
- Traditional Chinese medicine (TCM), Non-traditional Chinese medicine (non-TCM)
- Keywords
- Chronic Obstructive Pulmonary Disease in the Elderly, Cohort Study, Traditional Chinese Medicine Syndromes, Biomarkers
- 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.
Traditional Chinese medicine (TCM)Drug
According to the standardised use of TCM protocols, the group is divided into an exposed group (TCM cohort) and an unexposed group (non-TCM cohort).
Non-traditional Chinese medicine (non-TCM)Drug
All intervention measures that do not meet the criteria for TCM exposure are regarded as non-TCM exposure.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese Medicine cohort | Regulated use of Chinese medicine treatment protocols is included as an exposure factor. Receives: Drug: Traditional Chinese medicine (TCM) | |
| Non-Traditional Chinese Medicine cohort | Other elderly COPD patients who do not meet the inclusion criteria for traditional Chinese medicine cohort, are classified into the non-traditional Chinese medicine cohort. Receives: Drug: Non-traditional Chinese medicine (non-TCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual acute exacerbation rate
The annual acute exacerbation rate will be calculated in each group at the end of the trial.
Measured: Up to week 52.
Secondary outcomes (7)
Forced Vital Capacity (FVC)
FVC will be applied to assess pulmonary function.
Measured: Evaluate the FVC at weeks 26 and 52.
Forced Expiratory Volume in One Second (FEV1)
FEV1 will be applied to assess pulmonary function.
Measured: Evaluate the FEV1 at weeks 26 and 52.
FEV1/FVC Ratio
FEV1/FVC Ratio will be applied to assess pulmonary function.
Measured: Evaluate the FEV1/FVC Ratio at weeks 26 and 52.
6-Minute Walk Distance (6MWD)
The 6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.
Measured: Evaluate the 6MWD at weeks 26 and 52.
COPD Assessment Test (CAT) Score
The CAT score is a questionnaire used to evaluate the impact of COPD on patients' health status, which includes eight items: cough, phlegm, chest tightness, breathlessness, activity limitation, confidence in leaving home, sleep, and energy. The total CAT score ranges from 0 to 40, with higher scores indicating a greater disease burden and poorer health status.
Measured: Evaluate the CAT Score at weeks 13, 26, 39 and 52.
Modified Medical Research Council (mMRC) Dyspnea Scale
The mMRC is a scale used to evaluate the severity of dyspnea in patients, which consists of a single item with five grades ranging from 0 to 4. Higher grades indicate more severe dyspnea and greater limitations in daily activities.
Measured: Evaluate the mMRC at weeks 13, 26, 39 and 52.
St. George's respiratory questionnaire (SGRQ) total scores
The SGRQ is a scale used to evaluate the quality of life of patients, which includes three dimensions: symptoms, mobility, and the impact of disease on daily life, with a total of 50 items. The total score range of SGRQ is usually between 0 and 100, with higher scores leading to poorer quality of life.
Measured: Evaluate the SGRQ Score at weeks 13, 26, 39 and 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion28 Feb 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
- 2,386 participants (estimated)
- Target duration
- 52 Weeks
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Henan University of Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780682
- Sponsor's protocol ID
- Cohort for Elderly COPD
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Traditional Chinese Medicine Cohort Study of Chronic Obstructive Pulmonary Disease in the Elderly
- ClinicalTrials.gov ID
- NCT07780682
- Acronym / sponsor ID
- Cohort for Elderly COPD
- Keywords
- Chronic Obstructive Pulmonary Disease in the Elderly, Cohort Study, Traditional Chinese Medicine Syndromes, Biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,386 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Henan University of Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 21 Aug 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 study evaluates the real-world clinical efficacy of traditional Chinese medicine (TCM) in elderly Chronic obstructive pulmonary disease (COPD) patients and explores syndrome characteristics and their associations with biomarkers.
Detailed description
This prospective cohort study, with TCM as the exposure, will enroll 2,386 elderly COPD patients for a 1-year follow-up. The primary evaluation uses the annual acute exacerbation rate as the outcome to evaluate the clinical efficacy of TCM. In addition, the study will investigate the characteristics of TCM syndromes.
Based on the cohort, we will collect peripheral blood, exhaled breath condensate, sputum, and tongue coating samples from 200 elderly COPD patients with four typical TCM syndromes, 200 non-elderly COPD patients with corresponding syndromes, and 50 healthy volunteers. Multi-omics approaches will be used to identify TCM syndrome-related biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 52 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine cohort | – | Drug: Traditional Chinese medicine (TCM)Regulated use of Chinese medicine treatment protocols is included as an exposure factor. |
| Non-Traditional Chinese Medicine cohort | – | Drug: Non-traditional Chinese medicine (non-TCM)Other elderly COPD patients who do not meet the inclusion criteria for traditional Chinese medicine cohort, are classified into the non-traditional Chinese medicine cohort. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- COPD is a common chronic respiratory disease characterized by persistent respiratory symptoms and airflow limitation, with recurrent acute exacerbations and progressive impairment of respiratory function.
Key inclusion criteria (3 listed)
- Patients diagnosed with COPD;
- Age ≥ 60 years old;
- Voluntary participation in this study, and sign the informed consent form.
Key exclusion criteria (3 listed)
- Patients with various mental illnesses or other conditions that prevent normal communication;
- Patients with a history of pulmonary surgery, such as lung volume reduction surgery or lung transplantation;
- Patients with confirmed human immunodeficiency virus infection or acquired immunodeficiency syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Chinese medicine (TCM)According to the standardised use of TCM protocols, the group is divided into an exposed group (TCM cohort) and an unexposed group (non-TCM cohort). | Drug | Traditional Chinese Medicine cohort |
| Non-traditional Chinese medicine (non-TCM)All intervention measures that do not meet the criteria for TCM exposure are regarded as non-TCM exposure. | Drug | Non-Traditional Chinese Medicine cohort |
Primary outcome
Annual acute exacerbation rate
Time frame: Up to week 52.
The annual acute exacerbation rate will be calculated in each group at the end of the trial.
7 secondary outcomes
Forced Vital Capacity (FVC)
Time frame: Evaluate the FVC at weeks 26 and 52.
Forced Expiratory Volume in One Second (FEV1)
Time frame: Evaluate the FEV1 at weeks 26 and 52.
FEV1/FVC Ratio
Time frame: Evaluate the FEV1/FVC Ratio at weeks 26 and 52.
6-Minute Walk Distance (6MWD)
Time frame: Evaluate the 6MWD at weeks 26 and 52.
COPD Assessment Test (CAT) Score
Time frame: Evaluate the CAT Score at weeks 13, 26, 39 and 52.
Modified Medical Research Council (mMRC) Dyspnea Scale
Time frame: Evaluate the mMRC at weeks 13, 26, 39 and 52.
St. George's respiratory questionnaire (SGRQ) total scores
Time frame: Evaluate the SGRQ Score at weeks 13, 26, 39 and 52.
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 21 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingPhase 3
Study of Fluticasone/Formoterol/Glycopyrronium for the Treatment Chronic Obstructive Pulmonary Disease (TRIPLAR)
Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
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.
Jiansheng Li contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Henan University of Traditional Chinese Medicine at 1 site in China.
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 3 inclusion and 3 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 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Haifeng Wang (+86-0371-66207856, wangh_f@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual acute exacerbation rate (time frame: Up to week 52.). 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 21 Aug 2026.