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临床试验/NCT00369993
NCT00369993已完成2 期

A Randomised, Open Label, Five-way Crossover Study to Assess the Systemic Exposure of Fluticasone Propionate and Salmeterol From SERETIDE/ADVAIR 250HFA MDI Alone and With AeroChamber-Max Spacer and VOLUMATIC Both in Their Washed and Unwashed States in Adult Subjects With Mild or Intermittent Asthma

GlaxoSmithKline2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2005年3月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
20
试验地点
2
主要终点
The pharmacokinetic profile of fluticasone propionate (in particular the area under the curve to time t and the maximum concentration)

研究概览

简要总结

Spacers are used by people with respiratory diseases who have problems using MDIs (metered dose inhalers). This study used fluticasone propionate/salmeterol to look at the pharmacokinetic profiles produced by different spacers in their washed and un-washed states.

详细描述

A randomised, open label, five-way crossover study to assess the systemic exposure of fluticasone propionate and salmeterol from SERETIDE™/ADVAIR™ 250 HFA MDI without spacer and with AeroChamber-Max spacer and VOLUMATIC™ both in their washed and unwashed states in adult subjects with mild or intermittent 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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The pharmacokinetic profile of fluticasone propionate (in particular the area under the curve to time t and the maximum concentration)

次要结局

  • The pharmacokinetic profile of salmeterol and the time to maximum concentration of fluticasone propionate

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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