Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Bufei Yishen Granule for Reducing Acute Exacerbation in GOLD Stage 3 or 4 COPD: A Randomized, Double-blind, Placebo Controlled Trial
This study aims to establish the treatment scheme of Bufei Yishen granule for GOLD stage 3 or 4 chronic obstructive pulmonary disease (COPD), reducing acute exacerbation, improving exercise capacity 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. Frequent acute exacerbation and exercise limitation broadly exist in COPD
patients, especially those in GOLD stage 3 or 4. Although appropriate pharmacological
therapies have been proven to be effective in COPD management, however, many gaps are still
to be filled. For example, the adverse effects of pharmacologic therapies can never be
ignored. The investigator's previous studies suggested that traditional Chinese medicine
(TCM) has effect on GOLD stage 3 or 4 COPD.
This is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the
effect of Bufei Yishen granule on reducing acute exacerbation in GOLD stage 3 or 4 COPD
subjects. After a 14-day run-in period, 348 subjects will be randomly assigned to treatment
group or control group for 52-week treatment. The primary outcomes are frequency and duration
of acute exacerbation. The secondary outcomes include mortality, pulmonary function, clinical
symptoms, exercise capacity, quality of life and treatment satisfaction. Safety will also be
assessed.
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