Bronchial Thermoplasty (BT) Global Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 19
- 主要终点
- Proportion of patients who experience severe asthma exacerbations
研究概览
简要总结
The primary objective of this Registry is to collect real-world data on patients undergoing bronchial thermoplasty (BT) treatment.
详细描述
This Registry is a prospective, open-label, single arm, observational registry to collect outcome data as well as clinical and demographic characteristics of patients undergoing BT treatment in the "real world" setting. Patients will be recruited at participating study centers that offer BT as a treatment option to patients with asthma who remain symptomatic despite taking standard of care maintenance medications.
The Registry will be conducted at up to 80 sites globally and will enroll up to 500 patients. The treatment period is from the date of the first BT procedure until 6 weeks after the third (last) procedure (approximately 12 weeks). The post-treatment period starts at the date of the 6-week follow up visit after completion of the third (last) BT procedure for 2-years of follow-up.
The primary endpoint will be the proportion of patients who experience severe asthma exacerbations at 1 and 2 years following BT treatment with the Alair System.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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 and is scheduled to undergo BT treatment according to the Alair System DFU.
- •Patient is able to read, understand, and sign a written Informed Consent to participate in the Registry and able to comply with the registry requirements.
排除标准
- •Patient has any medical condition that would make them inappropriate for BT treatment, in the Investigator's opinion.
结局指标
主要结局
Proportion of patients who experience severe asthma exacerbations
时间窗: 2 years
The primary endpoint will be the proportion of patients who experience severe asthma exacerbations at 1 and 2 years following BT treatment with the Alair System.
次要结局
- Unscheduled office visits including urgent care visits for asthma symptoms.(2 years)
- Lung Volumes(2 years)
- Diffusion Capacity(2 years)
- Asthma maintenance medication use (Long Acting Beta Agonists, steroids etc.)(2 years)
- Patient satisfaction survey score(2 years)
- Exhaled nitric oxide (eNO)(2 years)
- Asthma Control Test (ACT) score(2 years)
- Emergency department visits for asthma symptoms(2 years)
- Pre- and post-bronchodilator Forced Expiratory Volume in one minute (FEV1)(2 years)
- Respiratory Adverse Events(2 years)
- Asthma Quality of Life Questionnaire (AQLQ) score(2 years)
- Allergic skin test or Radioallergosorbent Test (RAST) (perennial, seasonal, mold)(2 years)
- Methacholine challenge (Methacholine PC20)(2 years)
- Sputum eosinophils(2 years)
- Hospitalizations for asthma symptoms(2 years)