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.
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
2,386
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.
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, China
Annual acute exacerbation rate
The annual acute exacerbation rate will be calculated in each group at the end of the trial.
Time frame: Up to week 52.
Forced Vital Capacity (FVC)
FVC will be applied to assess pulmonary function.
Time frame: Evaluate the FVC at weeks 26 and 52.
Forced Expiratory Volume in One Second (FEV1)
FEV1 will be applied to assess pulmonary function.
Time frame: Evaluate the FEV1 at weeks 26 and 52.
FEV1/FVC Ratio
FEV1/FVC Ratio will be applied to assess pulmonary function.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Jiansheng Li
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Time frame: 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.
Time frame: Evaluate the SGRQ Score at weeks 13, 26, 39 and 52.