TASMA Extension Study: Long Term Efficacy and Safety of Bronchial Thermoplasty in Severe
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Emergency room visit for respiratory symptoms rate
研究概览
简要总结
This study evaluates the longterm clinical outcomes, including safety and efficacy parameters after Bronchial Thermoplasty (BT) treatment over a period of 5 years. All patients included in de TASMA trial in the Netherlands will be asked to participate in the TASMA extension study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject participation in the TASMA study
- •Ability and willingness to provide informed consent.
- •Ability to comply with the study protocol
排除标准
- •Subject participating in another clinical trial involving respiratory intervention which in the opinion of the investigator might interfere with the study.
结局指标
主要结局
Emergency room visit for respiratory symptoms rate
时间窗: measured yearly over 5 years
emergency room visits for respiratory symptoms/subject/year measured yearly over 5 years will be compared to the health care utilization pre- and 6 months post BT-treatment.
Hospitalization for respiratory symptoms rate
时间窗: measured yearly over 5 years
hospitalizations for respiratory symptoms/subject/year measured yearly over 5 years will be compared to the health care utilization pre- and 6 months post BT-treatment.
Severe exacerbations rate
时间窗: measured yearly over 5 years
exacerbations / subject / year measured yearly over 5 years will be compared to the health care utilization pre- and 6 months post BT-treatment.
次要结局
- Fractional exhaled nitric oxide (FeNO)(measured yearly over 5 years)
- Rescue medication use(measured yearly over 5 years)
- Airway-resistance (sRaw) mechanics(measured yearly over 5 years)
- Asthma Quality of Life Questionnaire (AQLQ) scores(measured yearly over 5 years)
- Airway smooth muscle (ASM) mass(2 years after inclusion, 2,5 years after BT)
- Asthma Control Questionnaire (ACQ) scores(measured yearly over 5 years)
- Pre-and post bronchodilator forced expiratory volume at one second (FEV1) and related FEV1 % reversibility(measured yearly over 5 years)
- provocative concentration causing a 20% fall (PC20 ) methacholine test(measured yearly over 5 years)
- Airway-conductance(sGaw) mechanics(measured yearly over 5 years)
- forced oscillation technique (FOT)(measured over 5 years)
- Maintenance dose of oral steroids(measured yearly over 5 years)
- Maintenance dose of inhaled steroids(measured yearly over 5 years)
- optical coherence tomography (OCT) determined changes(2 years after inclusion, 2,5 years after BT)
研究者
Prof J.T. Annema
Prof. Dr. J.T. Annema
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)