The Impact of an Anti-static Valved-holding Chamber on Bioavailability of Inhaled Fluticasone Propionate in Young Children With Asthma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- one-hour steady-state plasma concentration of fluticasone after each device
研究概览
简要总结
To compare lung delivery of fluticasone propionate delivered by HFA-pMDI, using a conventional polycarbonate of anti-static chamber/mask in a randomized crossover design in 1-6 year old children.
Hypothesis: Anti-static chamber/mask would increase the amount of inhaled corticosteroid delivered to young children who passively inhale and cannot breath hold.
详细描述
Objective -- to determine whether an anti-static chamber increases the one-hour steady-state fluticasone plasma concentration, which is an indirect measure of airway delivery and direct measure of systemic exposure. Twelve children 1-6 yrs with well-controlled persistent asthma were treated with HFA-FP pMDI, 2 actuations of 110 µg twice daily. The drug was administered by conventional polycarbonate or anti-static valved-holding chambers with masks in an unblinded, randomized, crossover manner each for at least three days. A blood sample was collected one hour after the last dose when adherence documented by electronic monitor was 100%. FP plasma concentrations were measured by liquid chromatography mass spectrometry assay. Results evaluated using regression analysis.
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
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children 1-6 years old; adequately controlled persistent asthma; currently receiving FP delivered by CFC MDI attached to valved-holding chamber/mask; ability to use chamber with mask effectively
排除标准
- •inadequately controlled asthma: nocturnal awakening > 2 nights/month, prn albuterol use > 2x/week, more than 2 short courses of oral corticosteroids in previous 3 months, missing a dose on more than one occasion, increase in asthma symptoms during study, inability to discontinue intranasal or dermal fluticasone for 3 days
结局指标
主要结局
one-hour steady-state plasma concentration of fluticasone after each device
次要结局
未报告次要终点