Effect of Bronchial Thermoplasty on Moderate Bronchial Asthma in China
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- change from baseline2 AQLQ score after Bronchial Thermoplasty
研究概览
简要总结
This study aims to investigate the efficacy and safety of Bronchial Thermoplasty on moderate bronchial asthma in China, by observing the improvement of quality of life, the decrease of acute attack and emergence, as well as the incidence of related complications.
详细描述
This is a multi-center, open-label and single arm study. At least 50 patients with moderate asthma receive Bronchial Thermoplasty for three times. Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Questionnaire (ACQ), Frequency of mild asthma acute attack, PEF, FEV1, Emergency and Hospitalization are compared between before and after BT treatment.
The unified peak flow test meter will be provided to all subjects enrolled in this study. They will get a follow-up diary book before leaving hospital. In order to ensure the efficiency, all enrolled asthma patients are trained and tested by doctors and nurses from in-patient or out-patient department when they follow up, including how to use the PEF meter, how to read and record the data. As for the dosage of medication, all the medication uses are followed the doctor's advice, once the rescue medications were used, the times and dosages are mandatory to be recorded in the diary book by the patients themselves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18y and 65y.
- •no improvement after ICS and LABA treatment in patients with moderate asthma
- •have not received BT before
- •stable more than 6 weeks before enrolled in this study
- •no implantable electrical device (e.g. cardiac pacemaker)
- •no permanent anticoagulant is being used
排除标准
- •Smoking and have obvious emphysema
- •Chest CT showed lower lobe bronchial stenosis or distal complete atelectasis
- •FEV1 < 65% predicted value after using bronchodilator
- •airway infection(within 6 weeks)
- •any circumstances as the following within the past 1 year: lower respiratory tract infection (LRTI) for 4 times or above; hospitalization due to respiratory diseases for more than 3 times; increase the dosage of oral corticosteroids due to asthma exacerbation for more than 4 times
- •received endotracheal intubation or ICU admission due to asthma attack within the past 2 years
- •concomitant allergic bronchopulmonary aspergillosis
- •Implantable electronic devices (such as cardiac pacemaker)/NYHA class IV and/or acute myocardial infarction within the past 3 months
- •coagulation disorders,cannot stop taking anticoagulant、antiplatelet drugs or nonsteroidal anti-inflammatory drugs
- •increasing the risk of adverse reactions during bronchoscopy or anesthesia as the followings: pregnancy, insulin-dependent diabetes, epilepsy, or the other severe complications, such as uncontrolled coronary heart disease, acute or chronic renal failure or uncontrolled hypertension
- •others:vocal cord dysfunction、chronic nasosinusitis、airway obstruction or uncontrolled obstructive sleep apnea syndrome
结局指标
主要结局
change from baseline2 AQLQ score after Bronchial Thermoplasty
时间窗: baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
次要结局
- decline from baseline 2 in the ACQ score for 0.5 or more(baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks)
- Frequency of mild asthma acute execration after Bronchial Thermoplasty(baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks)
- change from baseline2 peak flow after Bronchial Thermoplasty(baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks)
- change from baseline2 FEV1 after Bronchial Thermoplasty(baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks)
- change from baseline2 FEV1/FVC after Bronchial Thermoplasty(baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks)
- change from baseline2 FEV1 predicted after Bronchial Thermoplasty(baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks)
- the percentage of Emergency(baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks)
- Hospitalization and Asymptomatic days(baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks)
- the incidence of severe respiratory adverse events(baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks)
研究者
ShiYue Li
director
Guangzhou Institute of Respiratory Disease