Bufei Yishen Granule for Reducing Acute Exacerbation in GOLD Stage 3 or 4 COPD: A Randomized, Double-blind, Placebo Controlled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 348
- 试验地点
- 1
- 主要终点
- Duration of acute exacerbation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A confirmed diagnosis of GOLD stage 3 or 4 COPD.
- •Syndrome differentiation meets criteria of Qi deficiency of the lung and spleen syndrome, Qi deficiency of the lung and kidney syndrome or Qi and Yin deficiency of the lung and kidney syndrome.
- •Age ranges from 40 years to 80 years.
- •With informed consent signed.
排除标准
- •Pregnant and lactating women.
- •Patients with severe cardiovascular and cerebrovascular diseases.
- •Patients with severe liver and kidney diseases.
- •Patients with asthma, bronchiectasis, active pulmonary tuberculosis, pulmonary embolism, chronic respiratory failure or other severe respiratory diseases.
- •Patients with tumor after resection, radiotherapy or chemotherapy in the past 5 years.
- •Patients with severe neuromuscular disorders, severe arthritis or severe peripheral vascular diseases.
- •Patients with severe cognitive and psychiatric disorders.
- •Patients with diabetes.
- •Patients who were administered oral glucocorticoids in the past 4 weeks.
- •Patients who have participated in other clinical studies in the past 4 weeks.
- •People who are allergic to the treatment drugs.
- •Patients who have experienced one or more acute exacerbation in the past 4 weeks.
研究组 & 干预措施
Bufei Yishen granule plus Western medicine
Patients in this arm will receive Bufei Yishen granule in addition to Western medicine.
干预措施: Bufei Yishen granule (Drug)
Bufei Yishen granule plus Western medicine
Patients in this arm will receive Bufei Yishen granule in addition to Western medicine.
干预措施: Tiotropium Bromide Powder for Inhalation (Drug)
Placebo Bufei Yishen granule plus Western medicine
Patients in this arm will receive placebo Bufei Yishen granule in addition to Western medicine.
干预措施: Placebo Bufei Yishen granule (Drug)
Placebo Bufei Yishen granule plus Western medicine
Patients in this arm will receive placebo Bufei Yishen granule in addition to Western medicine.
干预措施: Tiotropium Bromide Powder for Inhalation (Drug)
结局指标
主要结局
Duration of acute exacerbation
时间窗: Up to week 52.
Duration of acute exacerbation will be recorded.
Frequency of acute exacerbation
时间窗: Up to week 52.
Frequency of acute exacerbation will be recorded.
次要结局
- Mortality(Up to week 52.)
- SF-36(Change from baseline SF-36 scores at week 13, 26, 39 and 52.)
- FEV1(Change from baseline FEV1 at week 26 and 52.)
- Clinical symptom assessment questionnaire(Change from baseline clinical symptom assessment questionnaire scores at week 13, 26, 39 and 52.)
- 6MWD(Change from baseline 6MWD at week 13, 26, 39 and 52.)
- CAT(Change from baseline CAT scores at week 13, 26, 39 and 52.)
- mCOPD-PRO(Change from baseline mCOPD-PRO scores at week 13, 26, 39 and 52.)
- mESQ-COPD(Change from baseline mESQ-COPD scores at week 13, 26, 39 and 52.)