NCT00739219终止4 期
Management of Asthma Patients Guided by Exhaled Nitric Oxide (eNO) Using the Apieron NO Analyzer
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Apieron
- 入组人数
- 260
- 试验地点
- 24
- 主要终点
- Asthma control days
研究概览
简要总结
This study is designed to show that pharmacotherapy guided by eNO and clinical standard of care produces a superior outcome to trial-based therapy guided by clinical standard of care alone.
详细描述
Patients with persistent, moderate to severe asthma will be randomized to receive therapy guided by either eNO and clinical standard of care (eNO group) or clinical standard of care (control group). An eNO treatment algorithm will be established for each patient in the eNO group at Baseline (Visit 1). Enrollment is estimated to be six months with a follow up period of twelve months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-existing diagnosis of asthma
- •Persistent, moderate or severe asthma as classified by NAEPP
- •Sub-optimally controlled asthma
- •Initiated ICS therapy for at least the past 30 days and a history of improvement of asthma control on steroids
排除标准
- •Active cigarette smoking or ≥ 10 pack-years smoking history
- •Xolair taken in the past 6 months prior to enrollment
- •Oral prednisone taken in the last 4 weeks prior to enrollment
- •Cystic Fibrosis, COPD, ciliary dyskinesia, chest wall deformities or scoliosis
- •Subject is currently enrolled in another investigational drug study
结局指标
主要结局
Asthma control days
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (24)
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