NCT00363740已完成3 期
Clinical Evaluation of GW685698 for Seasonal Allergic Rhinitis -A Placebo-controlled Study to Determine the Non-inferiority of GW685698 Over Fluticasone Propionate Using a Double-blind Manner-
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Mean change from baseline over the entire treatment period in three total nasal symptom scores.
研究概览
简要总结
This study was designed to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray and commonly used drug 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. Typical symptoms are 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
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Significant concomitant medical condition
- •Use of corticosteroids/allergy medications
- •Laboratory abnormality
- •Positive pregnancy test
- •Allergy to any component of investigational product
结局指标
主要结局
Mean change from baseline over the entire treatment period in three total nasal symptom scores.
次要结局
- Mean change from baseline over the entire treatment period in four total nasal symptom scores.
- Mean change from baseline over the entire treatment period in individual total nasal symptom scores.
研究者
研究点 (1)
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