Exhaled Nitric Oxide in Asthma Management: a Retrospective Real-life Observational Evaluation of the Use of Exhaled Nitric Oxide Measurements for Asthma Management in a UK Primary Care Population
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Proxy Asthma Control
研究概览
简要总结
This study will compare the absolute and relative effectiveness of managing real-life asthma with and without the use of NIOX MINO® and NIOX Flex® to measure exhaled nitric oxide (eNO) as a marker of underlying airway inflammation to guide appropriate management. As exhaled nitric oxide responds rapidly to environmental changes and can act as a marker of underlying inflammation it is proposed that incorporating eNO monitoring into routine asthma management treatment allows strategies to be more accurately tailored to the patients needs, increasing the probability of good asthma control.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 6 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged: 6-80 years
- •Evidence of active asthma (diagnostic code and/or ≥6 prescriptions for asthma therapy at any time in their records)
- •Evidence of current asthma treatment (≥2 asthma prescriptions during baseline year and outcome year)
- •Have at least one year of up-to-standard (UTS) baseline data and at least one year of UTS outcome data (following the IPD)
排除标准
- •Had a COPD read code at any time; and/or
- •Had any chronic respiratory disease, except asthma, at any time; and/or
- •Patients on maintenance oral steroids during baseline year
- •Smoker or ex-smoker aged over 60
结局指标
主要结局
Proxy Asthma Control
时间窗: One year outcome period
1. No recorded hospital attendance for asthma, including admission, Emergency Room (ER) attendance or Out-Patient Department (OPD) attendance, AND 2. No prescriptions for acute courses of oral steroids, AND 3. No GP consultations, hospital admissions or ER attendance for lower respiratory tract infections (LRTI) requiring antibiotics.
Severe Exacerbation Rate
时间窗: One Year Outcome Period
Where exacerbations are defined as an occurrence of: Unscheduled hospital admissions / Emergency Room attendance for asthma, OR Use of acute courses of oral steroids
次要结局
- Asthma Control (including SABA)(One year outcome)
- Respiratory-related hospitalisations and referrals(One year outcome period)
研究者
David Price, Prof., MD
David Price
Research in Real-Life Ltd