A Randomised, Double-blind, Placebo-controlled, Dose Ascending Crossover Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Inhaled GSK159797 Delivered by Dry Powder Inhaler in Mild to Moderate Asthmatic Subjects

GlaxoSmithKline0 个研究点目标入组 20 人开始时间: 2004年9月最近更新: 2016年9月1日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: GlaxoSmithKline
入组人数: 20
主要终点: Safety and tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and side effects.

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study was designed to test safety aspects and effects on lung function of a new dry powder version of GSK159797 for asthmatic subjects to inhale. This will allow comparison with previous studies which have only used inhalation of the drug as a vapour.

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: Double

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

未提供

排除标准

未提供

结局指标

主要结局

Safety and tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and side effects.

次要结局

Effects on the lung at 12 and 24hrs Effects on the heart, blood pressure and pulse rate at 8hrs Changes in the amount of glucose and potassium in the blood 4 and 8hrs Amount of drug in the body (blood and urine).

研究者

发起方

GlaxoSmithKline

申办方类型

Industry

责任方

Sponsor

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