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临床试验/NCT00215371
NCT00215371已完成2 期

Study in Patients With Asthma

Dey3 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2002年7月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
32
试验地点
3
主要终点
Primary: The primary efficacy outcome is measure of lung function.

研究概览

简要总结

The purpose of this study is to determine which dose of the investigational drug is safest and most effective compared to the control group.

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
5 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Require the regular use of an inhaled beta-2-selective adrenergic agent.
  • No clinically significant abnormalities on the medical history, physical examination, and clinical laboratory tests.

排除标准

  • Active acute or chronic disorders of the respiratory system within one month prior to screening.
  • Smoking history within the past 12 months or greater than a lifetime 10 pack-year smoking history.
  • Debilitating systemic and/or life-threatening diseases.

结局指标

主要结局

Primary: The primary efficacy outcome is measure of lung function.

次要结局

  • Secondary: Change in lung function will be examined as a secondary efficacy outcome, as well as vital signs, physical examination, adverse event reporting,etc.

研究者

发起方
Dey
申办方类型
Industry

研究点 (3)

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Study in Patients With Asthma | 临床试验