NCT00116883已完成3 期
A Randomized, Double-blind, Parallel Group, Placebo Controlled, 6-week Study of the Effect of GW685698X Aqueous Nasal Spray 100mcg QD on the Hypothalamic Pituitary Adrenocortical (HPA) Axis in Children 2 to 11 Years of Age With Perennial Allergic Rhinitis (PAR).
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- HPA axis function at baseline and after 6 weeks of treatment as measured by 24 hour urine and serial serum cortisol assessments in domiciled subjects
研究概览
简要总结
The purpose of this study is to assess the effect of an aqueous nasal spray investigational compound GW685698X compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system in children 2 to 11 years of age with perennial allergic rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 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
研究组 & 干预措施
Arm 1
Experimental
干预措施: GW685698X aqueous nasal spray (Drug)
结局指标
主要结局
HPA axis function at baseline and after 6 weeks of treatment as measured by 24 hour urine and serial serum cortisol assessments in domiciled subjects
次要结局
- Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments.
研究者
研究点 (1)
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