Yiqi Huoxue Huatan Granule for Reducing Mortality in COPD With Chronic Respiratory Failure: A Randomized, Double-blind, Placebo Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 372
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
This study aims to establish the treatment scheme of Yiqi Huoxue Huatan granule for chronic obstructive pulmonary disease (COPD) with chronic respiratory failure (CRF), reducing mortality, improving quality of life 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. COPD complicated by CRF is serious and has a high mortality rate. At present, ideal and effective treatment is inadequate. Traditional Chinese medicine (TCM) has some potential in improving outcomes in COPD with CRF.
This is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the effect of Yiqi Huoxue Huatan granule on reducing mortality and improving quality of life in COPD with CRF. After a 14-day run-in period, 372 subjects will be randomly assigned to treatment group or control group for 52-week treatment, followed by 52-week follow-up. The primary outcomes are all-cause mortality and frequency of acute exacerbation of COPD. The secondary outcomes include clinical symptoms, COPD assessment test (CAT), arterial blood gas analysis, pulmonary function and duration of mechanical ventilation. 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 stable COPD;
- •Arterial blood gas analysis meets criteria of PaO2 < 60mmHg and PaCO2 > 50mmHg during quiet breathing at sea level;
- •Syndrome differentiation meets criteria of Qi deficiency, blood stasis and phlegm turbidity obstructing orifice syndrome；
- •Age ranges from 40 years to 80 years;
- •With informed consent signed.
排除标准
- •• CRF resulting from other respiratory diseases, such as bronchiectasis, pulmonary cystic fibrosis, lung cancer, etc.;
- •Acute exacerbation of CRF；
- •Patients with severe cardiovascular and cerebrovascular diseases;
- •Pregnant and lactating women;
- •Patients with psychiatric disorders；
- •Patients with diabetes;
- •Patients who have participated in other clinical studies in the past 4 weeks;
- •Patients who have experienced one or more acute exacerbation of COPD in the past 4 weeks.
研究组 & 干预措施
Yiqi Huoxue Huatan granule plus Western medicine
Patients in this arm will receive Yiqi Huoxue Huatan granule in addition to Western medicine.
干预措施: Yiqi Huoxue Huatan granule (Drug)
Placebo Yiqi Huoxue Huatan granule plus Western medicine
Patients in this arm will receive placebo Yiqi Huoxue Huatan granule in addition to Western medicine.
干预措施: Placebo Yiqi Huoxue Huatan granule (Drug)
结局指标
主要结局
All-cause mortality
时间窗: Up to week 52 of the follow-up phase.
All-cause mortality will be calculated in this study.
Frequency of acute exacerbation of COPD
时间窗: Up to week 52 of the follow-up phase.
Frequency of acute exacerbation of COPD will be recorded.
次要结局
- Arterial partial pressure of oxygen (PaO2)(Change from baseline PaO2 at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.)
- Clinical symptom assessment questionnaire(Change from baseline clinical symptom assessment questionnaire scores at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.)
- FEV1(Change from baseline FEV1 at week 52 of the treatment phase, and week 52 of the follow-up phase.)
- Duration of mechanical ventilation(Change from baseline duration of mechanical ventilation at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.)
- Health economics(Up to week 52 of the follow-up phase.)
- Arterial partial pressure of carbon dioxide (PaCO2)(Change from baseline PaCO2 at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.)
- CAT(Change from baseline CAT scores at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.)
研究者
Fengcuiling
Professor
Peking University People's Hospital