Dose Response of FENO to Inhaled Steroids in Mild-to-moderate Asthma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in FENO
研究概览
简要总结
Asthma is a chronic disease, which means that it cannot be cured, but the investigators can use inhalers and tablets to control the symptoms. In asthma, the airways become inflamed and irritated which can cause coughing and make the airways tighten. This 'inflammation' is the root of the problem in asthma. Doctors have different ways to measure the inflammation in the airways. One way is to measure a gas called nitric oxide (NO) on the breath. This is made by the lungs when asthmatic inflammation is present. The investigators have been using NO as a test in research labs for many years, but there are still unanswered questions about how it changes between morning and night and how quickly medicines work on it. In most asthmatics, even small doses of inhaled steroids (preventers) can reduce the NO levels to normal, but in some people this does not seem to happen. The investigators now have portable NO machines that are designed for patients to use in the home. The investigators want to follow NO readings in patients with high levels to measure how they respond to different doses of steroid inhalers. The investigators hope this will help the investigators better understand asthma inflammation and treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis os asthma, taking 200-1000mcg budesonide or equivalent per day
- •FENO greater than 30ppb on treatment
排除标准
- •Recent RTI or prednisolone
- •Smoking within 1 year or 10 pack years
- •ABPA, COPD, bronchiectasis
研究组 & 干预措施
High dose ICS
Fluticasone Propionate 250mcg bid
干预措施: Fluticasone Propionate (Drug)
Low dose ICS
Fluticasone propionate 50mcg bid
干预措施: Fluticasone Propionate (Drug)
结局指标
主要结局
Change in FENO
时间窗: 2 weeks
次要结局
未报告次要终点
研究者
Brian J Lipworth
Professor
University of Dundee
