A Randomized, Open Label, Active Controlled (Mometasone Furoate Aqueous Nasal Spray [Nasonex®] 200mcg QD), Parallel Group, Multi-Center, 52-Week Study to Assess the Long Term Safety of GW685698X Aqueous Nasal Spray 100mcg QD Via Nasal Biopsy in Subjects 18 Years of Age With Perennial Allergic Rhinitis (PAR)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Quantitative and qualitative differences in the morphology and cytology of the nasal mucosa after 1 year of treatment.
研究概览
简要总结
Long term safety (52 weeks) of GW685698X on the nasal mucosa via nasal biopsy with an active control group (Nasonex®) and a healthy volunteers control group in subjects 18 years old with perennial allergic rhinitis . Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. Perennial allergic rhinitis is triggered by house dust mites, animal dander, etc., possibly causing symptoms year-round including nasal congestion, rhinorrhea and/or nasal itching.
详细描述
A Randomized, Open Label, Active Controlled (Mometasone Furoate Aqueous Nasal Spray [Nasonex®] 200mcg QD), Parallel Group, Multi-Center, 52-Week Study to Assess the Long Term Safety of GW685698X Aqueous Nasal Spray 100mcg QD via Nasal Biopsy in Subjects >18 Years of Age with Perennial Allergic Rhinitis (PAR)
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1
干预措施: GW685698X (Drug)
Arm 1
干预措施: mometasone furoate (Drug)
结局指标
主要结局
Quantitative and qualitative differences in the morphology and cytology of the nasal mucosa after 1 year of treatment.
次要结局
- No Secondary Outcome Measures