Measuring the Fractional Concentration of Exhaled Nitric Oxide (eNO) Using the Apieron INSIGHT System and the Aerocrine NIOX System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Apieron
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- eNO using Apieron INSIGHT(tm) System and Aerocrine NIOX at 50 ml/s
研究概览
简要总结
Collection of quantitative data to demonstrate the accuracy (bias) and precision (repeatability) of the Apieron INSIGHT(tm) eNO Breath System as compared to the FDA cleared NIOX eNO Breath System when testing is performed by asthma patients.
详细描述
A non-randomized, prospective study of up to 150 subjects with asthma. Patients will perform eNO testing with the Apieron INSIGHT(tm) eNO system and the NIOX eNO system at the physician's office/clinic after a short demonstration and training by a healthcare professional trained in the use of the devices. Exhaled NO testing involves inhaling to lung capacity, and then performing a controlled exhalation into a mouthpiece connected to each of the Apieron INSIGHT(tm) and NIOX systems. Patients will perform an eNO measurement with the Apieron INSIGHT(tm) system and with the FDA cleared NIOX system for the accuracy portion of the study. Patients will perform 2 sequential eNO measurements on each system for the precision part of the study. Subjects that measure eNO values over 100 ppb will be asked to repeat 2 sequential eNO measurements on each system.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 5 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 5 or older
- •Pre-existing diagnosis of asthma
- •Non-smoker
排除标准
- •Chronic inflammatory lung disease other than asthma
- •Medical conditions that preclude hand-eye coordination
结局指标
主要结局
eNO using Apieron INSIGHT(tm) System and Aerocrine NIOX at 50 ml/s
时间窗: Single point in time
次要结局
未报告次要终点
