TCM Cohort for Elderly COPD

August 19, 2026 updated by: Henan University of Traditional Chinese Medicine

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

2386

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Haifeng Wang
  • Phone Number: +86-0371-66207856
  • Email: wangh_f@126.com

Study Contact Backup

  • Name: Jiansheng Li

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • The First Affiliated Hospital of Henan University of Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Patients diagnosed with COPD;
  • Age ≥ 60 years old;
  • Voluntary participation in this study, and sign the informed consent form.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Traditional Chinese Medicine cohort
Regulated use of Chinese medicine treatment protocols is included as an exposure factor.
Drug: 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).
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.
Drug: Non-traditional Chinese medicine (non-TCM)
All intervention measures that do not meet the criteria for TCM exposure are regarded as non-TCM exposure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to week 52.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Vital Capacity (FVC)
Time Frame: Evaluate the FVC at weeks 26 and 52.
FVC will be applied to assess pulmonary function.
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 will be applied to assess pulmonary function.
Evaluate the FEV1 at weeks 26 and 52.
FEV1/FVC Ratio
Time Frame: Evaluate the FEV1/FVC Ratio at weeks 26 and 52.
FEV1/FVC Ratio will be applied to assess pulmonary function.
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.
The 6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.
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.
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.
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.
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.
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.
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.
Evaluate the SGRQ Score at weeks 13, 26, 39 and 52.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan University of Traditional Chinese Medicine

Collaborators

The First Affiliated Hospital of Guangzhou Medical University
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
The First Affiliated Hospital of Henan University of Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 20, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

February 28, 2030

Study Registration Dates

First Submitted

August 19, 2026

First Submitted That Met QC Criteria

August 19, 2026

First Posted (Actual)

August 21, 2026

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 19, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cohort for Elderly COPD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe