Determinants of Corticosteroid Insensitivity in Smokers With Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- bronchodilator response to oral corticosteroid trial in smokers with asthma vs non smokers and ex-smokers with asthma
研究概览
简要总结
Smokers with asthma display a relative insensitivity to inhaled and oral corticosteroids. The causes of this phenomenon are currently unknown. The investigators will perform a number of blood & breathing tests to try to discover the cause/s behind this phenomenon with the aim of producing leads for further investigation and possible new treatments for smokers with asthma.
详细描述
Smokers with asthma display a relative insensitivity to inhaled and oral corticosteroids. The causes of this phenomenon are currently unknown. However research into steroid resistance in severe asthma and the smoking related condition chronic obstructive pulmonary disease (COPD) points to a number of possible causes. We will characterise a group of smokers with asthma and perform a number of investigations and compare the results to ex-smokers and never smokers with asthma with the aim of establishing which previously published steroid resistance phenomena are related to the steroid resistance displayed by smokers with asthma. Results produced from this trial will provide hypothesis generating information leading to future pharmaceutical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asthma (defined by either reversibility to bronchodilator or methacholine testing)
- •Asthma duration of 6 months or greater
- •Stable asthma
- •Age 18-60
- •Treatment with inhaled corticosteroids
- •Smoking history consistent with group
- •smokers with asthma: > or = 5 pack years and currently smoking more than 5 cigarettes per day
- •ex-smokers: smoking ceased > or = two years prior to recruitment, minimum 5 pack year history
- •non-smokers: no smoking history
排除标准
- •Presence of medical condition likely to be exacerbated by treatment with oral corticosteroids
- •Treatment with > 2000 mcg beclomethasone (or equivalent) per day
- •Subject requires oral corticosteroids to maintain asthma control
- •Subject requires oral theophylline to maintain asthma control
- •Recent treatment with oral corticosteroids
- •Pregnancy or subject planning to become pregnant
研究组 & 干预措施
Group 1
Smokers with asthma
干预措施: oral steroid-dexamethasone (Drug)
Group 2
Ex-smokers with asthma
干预措施: oral steroid-dexamethasone (Drug)
Group 3
Non-smokers with asthma
干预措施: oral steroid-dexamethasone (Drug)
结局指标
主要结局
bronchodilator response to oral corticosteroid trial in smokers with asthma vs non smokers and ex-smokers with asthma
时间窗: 2 weeks
次要结局
未报告次要终点