Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Multi-center, Randomized, Double-blind, Controlled Study to Evaluate the Effectiveness of on Severe / Very Severe COPD Patients
The aim of this study is to compare the effectiveness of two treatments for severe / very severe COPD patients: one, conventional medicine based on 2013 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines; the other, TCM treatments and conventional medicine, which have been evaluated and have certain effect.
Patients with severe or very severe COPD are more likely to suffer repeated exacerbations
and more rapidly declining lung function generating increased risk of death and time to a
COPD related hospitalization. Although many therapies exist and are being developed to
relieve symptoms and reduce mortality in COPD, most have only been studied in moderate to
very severe COPD. There are few clinical trials to compare therapeutic alternatives in
severe and very sever COPD. Furthermore, some randomized controlled trials on comprehensive
Traditional Chinese medicine (TCM) interventions, especially based on the TCM patterns, have
been the certain evidence for showing definite effect for COPD patients. In addition, a
study about the effect of TCM on outcomes in mild and moderate COPD patients has been in
progress and will be carried out in December 2014 (NCT01486186). Hence, corresponding to the
mild to moderate COPD patients, The this study aims to evaluate the effectiveness of TCM on
severe / very severe COPD patients.
This is a multi-center, randomized, double-blind, controlled study to evaluate the
effectiveness of TCM on severe / very Severe COPD patients. Following a 14 day run-in
period, approximately 564 subjects will be randomly assigned to conventional medicine
treatment group, TCM and conventional medicine treatment group for 52 weeks. After the 52
weeks treatment period, subjects in two treatments arms will follow-up 52 weeks. The primary
outcome measure is the frequency of exacerbations. The secondary efficacy measures include
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) . Safety will
be assessed through the collection of adverse events. There will be a total of 9 study
visits (baseline, the 13, 26, 39 and 52 weeks of the treatment, the 13, 26, 39 and 52 weeks
of follow-up).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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