NCT04450108已完成不适用
Clinical Study of the Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients Responding to Inhaled Corticosteroid (ICS) Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 12
- 主要终点
- Change in FeNO Value
研究概览
简要总结
This is a multi-center study to evaluate fractional exhaled nitric oxide (FeNO) measured with the Vivatmo pro in adult and pediatric subjects.
详细描述
Subjects will be screened, enrolled and tested at Study Visit #1 and then prescribed inhaled corticosteroid (ICS) treatment as per routine clinical care. Subjects will return for Study Visit #2 in two weeks and repeat fractional exhaled nitric oxide (FeNO) measured with the Vivatmo pro
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 7 to 80 years of age.
- •Has been identified as a candidate for inhaled corticosteroid (ICS) treatment
- •Is willing and able to perform Vivatmo pro™ testing
排除标准
- •Subject has used corticosteroids prior to enrollment.
- •Subject has other current serious medical conditions
- •Subject has not been clinically stable for at least 2 weeks prior to the study
- •Subject is unwilling or unable to perform Vivatmo pro testing
结局指标
主要结局
Change in FeNO Value
时间窗: 14 days
Change in FeNO value before and after inhaled corticosteroid treatment
次要结局
未报告次要终点
研究者
研究点 (12)
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