Evaluation of the Efficiency of Bronchial Thermoplasty on Dynamic Hyperinflation in Uncontrolled Severe Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Evolution of dynamic hyperinflation
研究概览
简要总结
Bronchial thermoplasty is a treatment for severe asthma that consist in decreasing the thickness of bronchial muscle by heat using a catheter inserted into the bronchi under direct vision with the help of an endoscope This treatment has shown efficacy on symptoms, quality of life and the number of exacerbations related to severe asthma.
This clinical study evaluates the efficiency of this treatment on the dynamic hyperinflation phenomenon (worsening of bronchial obstruction during exercise in patients with asthma contributing to worsening shortness of breath).
详细描述
Bronchial thermoplasty is a recently validated bronchoscopic technique for the management of severe asthma that treats smooth muscle by radiofrequency to reduce its thickness. This procedure leads to improved asthma control and quality of life, but also to decreased exacerbations frequency and number of emergencies hospitalizations. This treatment requires 3 procedures every 3 to 4 weeks.
The pathophysiological mechanisms underlying its effectiveness need to be better understood for an improved selection of best candidates. In particular, there is a discrepancy between the improvement observed in symptoms (ACQ), quality of life (AQLQ) and the lack of improvement in forced expiratory volume in 1 second (FEV1). Investigator assume that this paradox is due to an efficiency appearing at effort, targeting dynamic hyperinflation phenomenon.
The objective of this study is to evaluate the influence of bronchial thermoplasty on dynamic hyperinflation in severe asthma. The secondary objectives are to assess the effectiveness of bronchial thermoplasty (ACQ, AQLQ) in a selected population of patients with dynamic hyperinflation and to describe bronchial wall structural changes by probe-based confocal LASER endomicroscopy (pCLE).
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
- •Severe asthma, uncontrolled despite optimal treatment according to GINA (global initiative for asthma) recommendations
- •At least 2 exacerbations treated by systemic steroids in the last year
- •FEV1 between 40 and 80% of predicted values and dynamic hyperinflation (defined as a decrease in inspiratory capacity by more than 500 ml during exercise)
排除标准
- •Current asthma exacerbation or respiratory infection
- •History of exacerbation after bronchoscopy
- •FEV1 < 40% of predicted values
- •Oxygen saturation < 90%
- •Contra-indications to ALAIR catheter system : pacemaker or other electronic implanted device
- •Allergy to Remifentanyl or Propofol
- •pregnancy; breastfeeding
研究组 & 干预措施
Intervention
Patients will be treated by three bronchial thermoplasty sessions.
干预措施: Bronchial thermoplasty for treatment of severe asthma (Procedure)
结局指标
主要结局
Evolution of dynamic hyperinflation
时间窗: 3 months
A lung plethysmography will be used to patients to see evolution of dynamic hyperinflation after bronchial thermoplasty, defined as a decrease in inspiratory capacity by more than 500 ml during exercise. The plethysmography will be made before the first procedure and three months after the third procedure.
次要结局
- Assess side effects(3 months)
- Structural modification of the bronchial wall(3 months)
- Efficiency of bronchial thermoplasty on asthma(3 months)