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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
612
Bufei Jianpi granule is composed of many kinds of traditional Chinese medicine. The granule will be administered twice daily for five days a week for 104 weeks.
Placebo Bufei Jianpi granule consists of dextrin, bitter and 5% of the Bufei Jianpi granule. The appearance, weight, color and odor of the preparation are the same as those of treatment group. The placebo granule will be administered twice daily for five days a week for 104 weeks.
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, China
FEV1
Forced expiratory volume in one second ( FEV1) will be used to assess pulmonary function.
Time frame: Change from baseline FEV1 at week 26, 52, 78 and 104.
Frequency of acute exacerbation
Frequency of acute exacerbation will be recorded.
Time frame: Up to week 104.
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, 52, 65, 78, 91 and 104.
mMRC
The modified Medical Research Council dyspnoea scale (mMRC) will be used to assess severity of dyspnea.
Time frame: Change from baseline mMRC scores at week 13, 26, 39, 52, 65, 78, 91 and 104.
6MWD
Six-minute walk distance (6MWD) will be conducted to assess exercise capacity.
Time frame: Change from baseline 6MWD at week 13, 26, 39, 52, 65, 78, 91 and 104.
CAT
The COPD assessment test (CAT) is a self-administered questionnaire that measures health-related quality of life.
Time frame: Change from baseline CAT scores at week 13, 26, 39, 52, 65, 78, 91 and 104.
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, 52, 65, 78, 91 and 104.
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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, 52, 65, 78, 91 and 104.
EQ-5D
EuroQol 5D (EQ-5D) will be used to assess quality of life.
Time frame: Change from baseline EQ-5D scores at week 13, 26, 39, 52, 65, 78, 91 and 104.
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, 52, 65, 78, 91 and 104.