The Effect of Once-daily Fluticasone Furoate on Methacholine-induced Bronchoconstriction in Mild Asthmatics
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Methacholine provocation dose causing a 20% fall in FEV1 (PD20)
研究概览
简要总结
The study will determine the effect of inhaled fluticasone furoate on airway responsiveness to methacholine in mild asthmatics.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •forced expiratory volume in one second (FEV1) greater than or equal to 65% predicted
- •methacholine PD20 less than or equal to 400mcg
- •no allergen exposure (if atopic) or respiratory infection for at least 4 weeks prior to study start
排除标准
- •regular use of inhaled corticosteroid within 4 weeks of study start
- •poorly controlled asthma
- •current smoker or ex smoker with greater than 10 pack year history
- •pregnancy or breast-feeding
- •health concern/condition that would preclude participation for safety reasons
研究组 & 干预措施
Fluticasone Furoate
Daily inhalation of 100mcg fluticasone furoate for 7 days Response to methacholine induced bronchoconstriction will be assessed on Day 1 before first inhalation of study treatment (baseline) and again at 24, 72 and 168 hours.
The change in airway responsiveness to methacholine will be determined as a dose shift in methacholine PD20 from baseline to each of the three timepoints
干预措施: Fluticasone furoate (Drug)
Matching Placebo
Daily inhalation of inactive placebo comparator for 7 days Response to methacholine induced bronchoconstriction will be assessed on Day 1 before first inhalation of study treatment (baseline) and again at 24, 72 and 168 hours.
The change in airway responsiveness to methacholine will be determined as a dose shift in methacholine PD20 from baseline to each of the three timepoints
干预措施: Matching placebo (Other)
结局指标
主要结局
Methacholine provocation dose causing a 20% fall in FEV1 (PD20)
时间窗: 24 hours post dose, 72 hours post dose and 168 hours post dose
Change from baseline in airway response to inhaled methacholine following daily dosing with fluticasone furoate or placebo
次要结局
- Fractional exhaled nitric oxide (FeNO)(168 hours)
- Sputum eosinophils(Baseline)
研究者
Don Cockcroft
Professor
University of Saskatchewan