Efficacy of Bronchial Thermoplasty in Korean Patients With Severe Asthma
试验速览
- 阶段
- 4 期
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Quality of Life Questionnaire for Adult Korean Ashtmatics - QLQAKA Questionnaire for Adult Korean Ashtmatics - QLQAKA
研究概览
简要总结
The investigators will find out if bronchial thermoplasty shows efficacy in reducing acute exacerbation and improving quality of life for uncontrolled asthma in Korea through this research. US FDA approved this procedure and CE mark was taken in Europe. Many procedure was performed in Western countries.
Korean FDA have approved this procedure in 2013. However, no procedure was performed in Korea, and the data is rare in Asian countries. In this study, investigators will examine the efficacy of this procedure in Korean asthmatics.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eighteen-year-old or older
- •Patients whose asthma is not controlled with more than three months of using high dose inhaled steroids and long acting β2-agonists
- •Patients with pre-bronchodilator FEV1 is between sixty and eighty-five%
- •Patients who do not improve through continuous drug uses.
排除标准
- •Presence of a pacemaker, internal defibrillator, or other implantable electronic devices,
- •Known sensitivity to medications required to perform bronchoscopy, including lidocaine, atropine, and benzodiazepines.
- •Patients previously treated with the Alair System should not be retreated in the same area(s). No clinical data are available studying the safety and/or effectiveness of repeat treatments.
- •Active respiratory infection
- •Asthma exacerbation or changing dose of systemic corticosteroids for asthma (up or down) in the past 14 days.
- •Known coagulopathy.
- •As with other bronchoscopic procedures, patients should stop taking anticoagulants, antiplatelet agents, aspirin and NSAIDS before the procedure with physician guidance.
研究组 & 干预措施
thermoplasty group
Check on the quality of life, emergency room uses, and sudden progress of the disease of the patients before and after the treatment by using bronchial thermoplasty system by using paired t test.
干预措施: bronchial thermoplasty system (Procedure)
结局指标
主要结局
Quality of Life Questionnaire for Adult Korean Ashtmatics - QLQAKA Questionnaire for Adult Korean Ashtmatics - QLQAKA
时间窗: 3 months
次要结局
- Quality of Life Questionnaire for Adult Korean Ashtmatics - QLQAKA Questionnaire for Adult Korean Ashtmatics - QLQAKA(6 months)
- Acute exacerbation(3,and 6 months)
研究者
Sei Won Lee
Department of Pulmonary and Critical Care Medicine and Clinical Research Center for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan College of Medicine
Asan Medical Center