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临床试验/NCT00739531
NCT00739531已完成不适用

Measuring the Fractional Concentration of Exhaled Nitric Oxide (eNO) Using the Apieron INSIGHT System and the Aerocrine NIOX System

Apieron2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2007年10月最近更新:
适应症

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

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

研究者

发起方
Apieron
申办方类型
Industry

研究点 (2)

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