NCT00641680已完成3 期
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-group, Phase IIIb Study to Assess the Efficacy, Safety & Product Attributes of Rhinocort Aqua(Budesonide) Versus Placebo and FluticasonePropionate as an Active Comparator in Patients 12yrs Age &Older With SeasonalAllergicRhinitis
适应症
干预措施
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
- 750
- 主要终点
- To compare once daily treatment with Rhinocort against placebo and at reliving the nasal symptoms of seasonal allergic rhinitis.
研究概览
简要总结
The purpose of this study is to compare once daily treatment with Rhinocort against placebo and Fluticasone Propionate at reliving the nasal symptoms of seasonal 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
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least a 2 year documented history of seasonal allergic rhinitis
- •who, in the opinion of the investigator,
- •is a candidate for treatment with nasal steroids based on a history of either
- •a)inadequate control of symptoms with antihistamines, decongestants and/or immunotherapy, or
- •b) prior successful treatment with nasal steroids.
- •A positive response to a skin prick test at Visit 1 or within the last 12 months for grass allergens that must be present in the subject's environment for the duration of the study.
排除标准
- •Primary or secondary adrenal insufficiency
- •Nasal candidiasis, rhinitis medicamentosa, acute or chronic sinusitis, influenza, upper respiratory tract infection or structural abnormalities of the nose (e.g., septal deviation, nasal polyps) symptomatic enough to cause significant nasal obstruction as judged by the investigator.
- •A diagnosis of asthma requiring treatment as specifies in the protocol.
研究组 & 干预措施
1
Experimental
Budesonide
干预措施: Budesonide (Drug)
2
Active Comparator
Fluticasone propionate
干预措施: Fluticasone propionate (Drug)
3
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To compare once daily treatment with Rhinocort against placebo and at reliving the nasal symptoms of seasonal allergic rhinitis.
时间窗: 2 weeks
次要结局
- To compare once daily treatment with Rhinocort against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.(2 weeks)
- To compare once daily treatment with placebo against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.(2 weeks)
- Safety assessment via adverse events and clinical measurements.(2 & 4 weeks)
研究者
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