Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Bufei Jianpi Granule for Delaying Pulmonary Function Decline in Early-Stage COPD: A Randomized, Double-blind, Placebo Controlled Trial
This study aims to establish the treatment scheme of Bufei Jianpi granule for early-stage (GOLD stage 1 or 2) chronic obstructive pulmonary disease (COPD), delaying pulmonary function decline and forming high quality evidence.
COPD is a highly prevalent disease, with a prevalence among people 40 years of age or older
of 10.1% worldwide and 13.7% in China. COPD has become the third leading cause of death
worldwide. More than 70% of patients with COPD are in GOLD stage 1 (mild) or 2 (moderate),
with very mild or no apparent respiratory symptoms such as dyspnea. The Tiotropium in Early
Chronic Obstructive Pulmonary Disease Patients in China (Tie-COPD) trial was designed to
investigate the effect of tiotropium on the FEV1 in COPD patients with GOLD stage 1 or 2. The
investigator's previous studies also suggested that traditional Chinese medicine (TCM) has
effect on GOLD stage 1 or 2 COPD.
This is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the
effect of Bufei Jianpi granule for delaying pulmonary function decline in early-stage (GOLD
stage 1 or 2) COPD subjects. After a 14-day run-in period, 612 subjects will be randomly
assigned to treatment group or control group for 104-week treatment. The primary outcomes
include pulmonary function and frequency of acute exacerbation. The secondary outcomes
include clinical symptoms, dyspnea, exercise capacity, quality of life and treatment
satisfaction. Safety will also be assessed.
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