NCT00225823已完成3 期
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Two Week Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis in Europe
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 25
- 主要终点
- Mean change from baseline over the entire treatment period in daily, reflective, total nasal symptom scores (rTNSS).
研究概览
简要总结
Compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as 'hay fever', it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent.
- •Must be an outpatient.
- •Females must be using appropriate contraception.
- •Must have diagnosis of seasonal allergic rhinitis, adequate exposure to allergen.
- •Must be able to comply with study procedures.
- •Must be literate.
排除标准
- •A significant concomitant medical condition.
- •Use of corticosteroids or allergy or medications or tobacco.
- •Clinically significant abnormal ECG.
- •Laboratory abnormality.
- •Positive pregnancy test.
- •Allergy to any component of the investigational product.
结局指标
主要结局
Mean change from baseline over the entire treatment period in daily, reflective, total nasal symptom scores (rTNSS).
次要结局
- Mean change from baseline over the entire tx period in AM, pre-dose iTNS. Mean change from baseline over the entire treatment period in rTOSS. Overall evaluation of response to therapy.
研究者
研究点 (25)
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