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NCT Number: NCT07780682

TCM Cohort for Elderly COPD

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, 450000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Forced Vital Capacity (FVC)

    Time frame: Evaluate the FVC at weeks 26 and 52.

    FVC will be applied to assess pulmonary function.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Haifeng Wang

CONTACT

[email protected]

+86-0371-66207856

Jiansheng Li

CONTACT

Sponsors and collaborators

Lead sponsor

Henan University of Traditional Chinese Medicine

Other

Collaborators

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

Registry information

Official study title

A Prospective Traditional Chinese Medicine Cohort Study of Chronic Obstructive Pulmonary Disease in the Elderly

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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