TCM Cohort for Elderly COPD

NCT07780682 | Not Yet Recruiting DMC

• 1 other identifier: Cohort for Elderly COPD
• Study Type: observational
• Target: 2,386
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease in the Elderly; Cohort Study; Traditional Chinese Medicine Syndromes; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Annual acute exacerbation rate

  The annual acute exacerbation rate will be calculated in each group at the end of the trial.

  Up to week 52.

Secondary Outcomes (7)

• Forced Vital Capacity (FVC)

  Evaluate the FVC at weeks 26 and 52.

• Forced Expiratory Volume in One Second (FEV1)

  Evaluate the FEV1 at weeks 26 and 52.

• FEV1/FVC Ratio

  Evaluate the FEV1/FVC Ratio at weeks 26 and 52.

• 6-Minute Walk Distance (6MWD)

  Evaluate the 6MWD at weeks 26 and 52.

• COPD Assessment Test (CAT) Score

  Evaluate the CAT Score at weeks 13, 26, 39 and 52.

Study Arms (2)

Traditional Chinese Medicine cohort

Regulated use of Chinese medicine treatment protocols is included as an exposure factor.

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.

Drug: Non-traditional Chinese medicine (non-TCM)

Interventions

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).

Traditional Chinese Medicine 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.

Non-Traditional Chinese Medicine cohort

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Henan University of Chinese Medicine: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Henan University of Traditional Chinese Medicine: lead
• First Teaching Hospital of Tianjin University of Traditional Chinese Medicine: collaborator

Study Sites (1)

The First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, 450000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biospecimen Description: Blood, Exhaled breath condensate, Tongue coating, Sputum

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Medicine, Chinese Traditional

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies; Therapeutics

Central Study Contacts

Haifeng Wang

CONTACT

+86-0371-66207856; wangh_f@126.com

Jiansheng Li

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 52 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 21, 2026
• Study Start: August 20, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): February 28, 2030
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)