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临床试验/NCT00995657
NCT00995657已完成4 期

Dose Response of FENO to Inhaled Steroids in Mild-to-moderate Asthma

University of Dundee1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Fluticasone Propionate 250mcg bid

干预措施: Fluticasone Propionate (Drug)

Low dose ICS

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brian J Lipworth

Professor

University of Dundee

研究点 (1)

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