Study of Physiopathological Mechanisms and Results of Treatment With Bronchial Thermoplasty in Severe Asthma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Bronchial smooth muscle.
研究概览
简要总结
The purpose of this study is to evaluate clinical and histological response to bronchial thermoplasty in severe asthma patients.
详细描述
Bronchial thermoplasty is a new therapeutic tool for severe and uncontrolled asthma patients. Clinical trials have demonstrated clinical benefits regarding quality of life and exacerbations. Animal models suggested the reduction of bronchial smooth muscle as the principal responsible for the clinical benefits observed in asthma patients treated in the clinical trials, although there is little information about its mechanism of action, and limited to a very small number of case reports. Given that the mechanism of action of bronchial thermoplasty is still not well understood, we proposed a biological study in asthma patients treated with bronchial thermoplasty with the purpose to analyze changes in inflammatory markers and histological samples, as well as its correlation with clinical outcomes in real practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Patients under 18 years old.
- •Severe persistent asthma according to GINA.
- •Inhaled corticosteroids and long-acting ß2 agonist (LABA).
- •Other medications for asthma, as oral corticosteroids, anti-IgE, theofiline, etc. are also acceptable.
- •Asthma Quality of Life Questionnaire (AQLQ) < 7
- •Asthma Control Test (ACT) < 19
- •≥ 2 exacerbations in last year
排除标准
- •History of cigarette smoking with > 15 pack/years.
- •Other respiratory diseases.
- •Comorbidity that can justify the symptoms of the patients.
- •Life-threating unstable asthma.
- •Any contraindication to perform a bronchoscopy (respiratory insufficiency, coagulation abnormalities, allergy to sedative drugs, etc.)
研究组 & 干预措施
Bronchial thermoplasty
ALAIR Catheter. Radiofrequency system.
干预措施: ALAIR Catheter. Radiofrequency system. (Device)
结局指标
主要结局
Bronchial smooth muscle.
时间窗: Change from baseline in bronchial smooth muscle at 6 months post-treatment..
次要结局
- Number of exacerbations(Change from baseline in number of exacerbations at 6 months post-treatment.)
- Number of hospitalizations(Change from baseline in number of hospitalizations at 6 months post-treatment.)
- Respiratory function(Change from baseline in respiratory function at 6 months post-treatment.)
- Radiological findings (thorax HRCT scan)(Change from baseline in radiological findings at 6 months post-treatment.)
- Questionnaire of Quality of life (AQLQ)(Change from baseline in AQLQ at 6 months post-treatment.)
- Questionnaire of asthma control (ACT)(Change from baseline in ACT at 6 months post-treatment.)
- Inflammatory markers(Change from baseline in biological inflammatory markers at 6 months post-treatment.)