Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Multi-center, Prospective, Cohort Study to Evaluate the Effectiveness of Traditional Chinese Medicine on COPD Patients
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).
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Observational Model: Cohort, Time Perspective: Prospective
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