NCT00163488已完成3 期
Investigation of Potential Additive Inhibitory Effects on HPA-Axis of Ciclesonide Nasal Spray When Administered Concomitantly With Orally Inhaled Fluticasone Propionate/Salmeterol (FP/SAL) in Patients (18-60 Years) With Perennial Allergic Rhinitis (PAR)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- safety.
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of combined ciclesonide nasal spray administered along with a fixed combination of inhaled fluticasone dipropionate/salmeterol.
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
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General good health, other than perennial allergic rhinitis
- •History and diagnosis of perennial allergic rhinitis by skin prick
- •Normal body weight as defined by the study protocol
排除标准
- •Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the study period
- •Participation in any investigational drug trial within the 30 days preceding the Screening Visit
- •A known hypersensitivity to any corticosteroid or any of the excipients in the formulations
- •Use of any prohibited concomitant medications as defined by the study protocol
- •Previous participation in an intranasal ciclesonide study
- •Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit
结局指标
主要结局
safety.
次要结局
- safety and tolerability.
研究者
研究点 (2)
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