NCT00829257已完成4 期
A Proof of Concept Study to Evaluate the Additive Effects of HFA-BDP (Qvar) to Fluticasone/Salmeterol (Seretide) on Surrogate Markers of Small and Large Airway Inflammation in Refractory Asthma
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
- 15
- 试验地点
- 1
- 主要终点
- Alveolar nitric oxide
研究概览
简要总结
The purpose of this study is to establish whether addition of extra-fine particle steroid inhalers achieve additional suppression of small airways inflammation when added to 'standard' Fluticasone/Salmeterol combination therapy in refractory asthma.
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
- None
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
- •Refractory, non-smoking asthmatics with FEV1 les than 80% predicted
- •RV greater than 100% predicted and CANO greater than 3ppb when stepped up to 1000µg of fluticasone per day, with or without additional asthma medication.
- •Informed consent and ability to perform exhaled nitric oxide assessment.
- •Participants must be on greater than 500mcg of fluticasone per day to enter dose ramp run-in.
排除标准
- •Recent respiratory infection or oral steroid use.
- •Pregnancy or lactation.
- •Known or suspected contra-indication to any of the IMP's.
- •CANO less than 3ppb, FEV1 greater than 80% or RV less than 100% at post-optimisation visit.
研究组 & 干预措施
Fine particle steroid inhaler
Experimental
HFA-BDP plus Fluticasone/Salmeterol Combination
干预措施: HFA-BDP (Drug)
Fine particle steroid inhaler
Experimental
HFA-BDP plus Fluticasone/Salmeterol Combination
干预措施: Seretide (Drug)
Coarse Particle Inhaler
Active Comparator
FP plus Fluticasone/Salmeterol combination
干预措施: Fluticasone (Drug)
Coarse Particle Inhaler
Active Comparator
FP plus Fluticasone/Salmeterol combination
干预措施: Seretide (Drug)
结局指标
主要结局
Alveolar nitric oxide
时间窗: 16 weeks
次要结局
未报告次要终点
研究者
Brian J Lipworth
Professor
University of Dundee
研究点 (1)
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