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临床试验/NCT00327353
NCT00327353已完成4 期

Single-Centre Randomised Open Crossover Study to Examine the Influence of Different Internal Resistances of Discus and Turbohaler Respectively on the Effects of Salmeterol and Formoterol in Asthmatic Subjects

GlaxoSmithKline3 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2004年1月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
77
试验地点
3
主要终点
Forced expiratory volume in 1 second (FEV1) under time curve 0.5-6 hours after inhalation of study medication

研究概览

简要总结

Effect of inhaled drugs administered as dry powder is not only dependent on drug efficacy but also on technical properties of the inhalers. Different inhalers have different internal resistances and therefore it is expected that patients with limited airflow may have different exposure rates of drugs delivered from different devices

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 —(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

Forced expiratory volume in 1 second (FEV1) under time curve 0.5-6 hours after inhalation of study medication

次要结局

  • Airway resistances and peak FEV1 measured 0.5, 1, 2, 4 and 6 hours after inhalation of study drug

研究者

申办方类型
Industry

研究点 (3)

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