Spirometric Response to Bronchial Thermoplasty in Patients With Severe Asthma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary endpoints are improvements in prebronchodilator FEV1 and FVC.
研究概览
简要总结
The investigators hypothesis is that there will be improvement in FEV1 in patients with severe asthma. This is a retrospective data study that reviews preexisting medical records; no patients will be enrolled.
详细描述
The investigators plan is to retrospectively evaluate spirometry on patients with severe asthma who have undergone bronchial thermoplasty. The procedure will have been done according to the recommended protocol of three separate sessions. For each patient all available spirometric data obtained before and after thermoplasty will be used. Data will be collected from two centers, OU Medical Center and St. Francis Hospital in Tulsa, OK. All procedures done at St. Francis have been performed by a single physician and he is providing their spirometric data for the investigators study. The following data will be collected for all participants undergoing bronchial thermoplasty: Age, height, sex, weight, medical history, smoking history, baseline spirometry before and after bronchodilators, post thermoplasty spirometry before and after bronchodilators.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years of age
- •severe asthma diagnosis
- •decreased FEV1
排除标准
- •< 18 years of age
结局指标
主要结局
The primary endpoints are improvements in prebronchodilator FEV1 and FVC.
时间窗: 1 year after thermoplasty
The primary endpoints are improvements in prebronchodilator FEV1 and FVC by 12% predicted.
次要结局
- Secondary endpoints are improvements in postbronchodilator FEV1 and FVC and degree of bronchodilator responsiveness.(1 year after thermoplasty)