Registry of Bronchial Thermoplasty (BT) Procedures in China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Incidence of severe asthma exacerbations following BT with the Alair System.
研究概览
简要总结
The objective of this Registry is to collect real-world outcome data for bronchial thermoplasty (BT) procedures in patients with severe persistent asthma who remain symptomatic despite taking standard of care maintenance medications.
详细描述
Data will be used to confirm the impact of BT on safety, effectiveness, quality of life, and the anticipated reduction in healthcare utilization events and cost by way of a reduction in severe asthma exacerbations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient is an adult aged 18 years or older with severe persistent asthma who remains symptomatic despite taking standard of care maintenance medications.
- •Patient is able to read, understand, and sign a written Informed Consent to participate in the Registry and able to comply with the study requirements.
- •Patient is able to undergo bronchoscopy in the opinion of the Investigator or per hospital guidelines and as described in the Alair System Directions for Use (DFU).
排除标准
- •Patient has an implanted electrical stimulation device (e.g., a pacemaker, cardiac defibrillator, or deep nerve or deep brain stimulator).
- •Patient has any other medical condition that would make them inappropriate for study participation, in the Investigator's opinion.
结局指标
主要结局
Incidence of severe asthma exacerbations following BT with the Alair System.
时间窗: 1 year
Severe asthma exacerbation is defined as worsening of asthma symptoms requiring use of systemic corticosteroids (tablets, suspension, or injection) (NAEPP Guidelines, 2007). For patients already taking oral corticosteroids on a daily or alternate day basis, a severe asthma exacerbation is defined as a worsening of asthma symptoms requiring any increase in daily dose of systemic corticosteroids. For consistency, courses of corticosteroids separated by 1 week or more will be treated as separate severe exacerbations.
次要结局
- Quarlity of life of Patients(1 year)
- Health care utilization(1 year)
- FEV1(1 year)
- Serious respiratory adverse events(1 year)