Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
Chronic Obstructive Pulmonary Disease in the Elderly, Cohort Study, Traditional Chinese Medicine Syndromes, Biomarkers
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.
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.
Interventions
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).
All intervention measures that do not meet the criteria for TCM exposure are regarded as non-TCM exposure.
Sponsors
Henan University of Traditional Chinese Medicine
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 design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annual acute exacerbation rate | Up to week 52. | The annual acute exacerbation rate will be calculated in each group at the end of the trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forced Vital Capacity (FVC) | Evaluate the FVC at weeks 26 and 52. | FVC will be applied to assess pulmonary function. |
| Forced Expiratory Volume in One Second (FEV1) | Evaluate the FEV1 at weeks 26 and 52. | FEV1 will be applied to assess pulmonary function. |
| FEV1/FVC Ratio | Evaluate the FEV1/FVC Ratio at weeks 26 and 52. | FEV1/FVC Ratio will be applied to assess pulmonary function. |
| 6-Minute Walk Distance (6MWD) | 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. |
| COPD Assessment Test (CAT) Score | 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. |
| Modified Medical Research Council (mMRC) Dyspnea Scale | 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. |
| St. George's respiratory questionnaire (SGRQ) total scores | 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. |
Countries
China
Contacts
CONTACTHaifeng Wang
CONTACTJiansheng Li
Outcome results
None listed