The aim of this study is to compare the effectiveness of the treatments in two cohort for COPD patients: one, traditional Chinese medicine (TCM) cohort, which have been evaluated and have certain effect; the other, conventional medicine treatments cohort, based on 2015 Global Initiative for Chronic Obstructive Lung Disease (GOLD).
COPD, with high prevalence, morbidity, mortality and economic burdens, affects millions worldwide. Although many therapies exist and are being developed to relieve symptoms and reduce mortality in COPD, most have only been studied in placebo-controlled efficacy studies in highly selected populations. There are few clinical trials to compare therapeutic alternatives in real world. Furthermore, some randomized controlled trials on comprehensive TCM interventions, especially based on the TCM patterns, have been the certain evidence for showing definite effect for COPD patients. In addition, studies in real world populations of COPD that received different therapies that do have efficacy evidence was found wide variations in care delivery. In short, there is a need for cohort study in COPD. This is a multi-center, prospective, cohort study to evaluate the effectiveness of TCM on COPD patients. The cohort study will enroll approximately 2540 patients that in two cohort, one, TCM cohort, which have been evaluated and have certain effect; the other, conventional medicine treatments cohort, based on 2015 Global Initiative for Chronic Obstructive Lung Disease (GOLD).Subjects in two cohort will be followed-up 2 years.The primary outcome measure is the frequency of exacerbations. The secondary efficacy measures include mortality rate and all-cause mortality, FEV1, dyspnea (MMRC), exercise capacity( 6MWD), quality of life ( CAT, SF-36 and COPD-PRO), and effectiveness satisfaction with treatment(ESQ-COPD).
Study Type
OBSERVATIONAL
Enrollment
2,540
The frequency of exacerbation
Time frame: Change from Baseline in the frequency of exacerbation at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
All cause mortality
Time frame: The all-cause mortality in 2 years of the follow up phase.
Forced expiratory volume in one second
FEV1 is the amount of air that can be exhaled in one second.
Time frame: Change from Baseline in the one second (FEV1) at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
Dyspnea
Using Modified Medical Research Council (MMRC) scale to assess a patient's level of dyspnea. The MMRC scale is a simple grading system that scored from 0 (less severe) to 4 (severe).
Time frame: Change from Baseline in MMRC at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
Minutes Walking Distance Test (6MWD)
Time frame: Change from Baseline in the 6MWD at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
COPD Assessment Test (CAT)
Using the CAT to evaluate the impact of COPD on a person's life over time.
Time frame: Change from Baseline in the CAT at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
Effectiveness satisfaction with treatment
Using the effectiveness satisfaction questionnaire of chronic obstructive pulmonary disease (ESQ-COPD) to evaluate COPD patients' satisfaction with their treatment over time.
Time frame: Change from Baseline in the ESQ-COPD at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
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Short Form 36-Item Health Survey (SF-36)
Using the SF-36 to evaluate the impact of COPD on a person's life over time.
Time frame: Change from Baseline in the SF-36 at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
Patient reported outcome for COPD (COPD-PRO)
Using the COPD-PRO to evaluate the impact of COPD on a person's life over time.
Time frame: Change from Baseline in the COPD-PRO at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.