NCT00641979已完成2 期
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Functionality of a New Nasal Device With Reformulated Rhinocort Aqua (Budesonide) Versus the Current Product and Versus Placebo in Subjects With Seasonal Allergic Rhinitis (SAR).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 200
- 主要终点
- Assessment of Total Nasal Symptom scores (Rhinorrhea, Congestion, Itching & Sneezing)
研究概览
简要总结
The purpose of this study is to compare the efficacy of once daily dosing with Rhinocort Aqua (new formulation) against Rhinocort Aqua (current formulation) and placebo in reliving the symptoms of seasonal allergic rhinitis (SAR).
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 documented history of at least one year of seasonal allergic rhinitis.
- •A positive response to a skin prick test for grass allergens that must be present in the subject's environment throughout 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 specified in the protocol.
研究组 & 干预措施
2
Placebo Comparator
干预措施: Placebo (Drug)
1
Experimental
Rhinocort
干预措施: Budesonide (Device)
结局指标
主要结局
Assessment of Total Nasal Symptom scores (Rhinorrhea, Congestion, Itching & Sneezing)
时间窗: 2 weekly
次要结局
- Durability of device(End of study)
- Safety assessment via adverse events and clinical measurements(2 weekly)
研究者
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