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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
348
Bufei Yishen granule will be administered twice daily for five days a week for 52 weeks.
Placebo Bufei Yishen granule will be administered twice daily for five days a week for 52 weeks. The placebo granule consists of dextrin, bitter and 5% of the Bufei Yishen granule. The appearance, weight, color and odor of the preparation are the same as those of treatment group.
Tiotropium Bromide Powder for Inhalation will be used once daily (18 μg each time) for 52 weeks.
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, China
Frequency of acute exacerbation
Frequency of acute exacerbation will be recorded.
Time frame: Up to week 52.
Duration of acute exacerbation
Duration of acute exacerbation will be recorded.
Time frame: Up to week 52.
Mortality
The mortality will be calculated.
Time frame: Up to week 52.
FEV1
Forced expiratory volume in one second ( FEV1) will be used to assess pulmonary function.
Time frame: Change from baseline FEV1 at week 26 and 52.
Clinical symptom assessment questionnaire
Clinical symptom assessment questionnaire of COPD will be used to assess symptom.
Time frame: Change from baseline clinical symptom assessment questionnaire scores at week 13, 26, 39 and 52.
6MWD
Six-minute walk distance (6MWD) will be conducted to assess exercise capacity
Time frame: Change from baseline 6MWD at week 13, 26, 39 and 52.
CAT
COPD assessment test (CAT) will be used to assess quality of life.
Time frame: Change from baseline CAT scores at week 13, 26, 39 and 52.
SF-36
The MOS 36-Item Short-Form Health Survey (SF-36) will be used to assess quality of life.
Time frame: Change from baseline SF-36 scores at week 13, 26, 39 and 52.
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mCOPD-PRO
The modified COPD patient-reported outcome scale (mCOPD-PRO) will be used to assess quality of life. The mCOPD-PRO contains 27 items in three domains. mCOPD-PRO scores range from 0 to 4 with a decrease in score showing higher health status.
Time frame: Change from baseline mCOPD-PRO scores at week 13, 26, 39 and 52.
mESQ-COPD
The modified effectiveness satisfaction questionnaire for COPD (mESQ-COPD) will be used to assess treatment satisfaction. The mESQ-COPD contains 19 items in four domains. mESQ-COPD scores range from 0 to 4 with a decrease in score showing higher treatment satisfaction.
Time frame: Change from baseline mESQ-COPD scores at week 13, 26, 39 and 52.