NCT01033396已完成2 期
A Randomized, Double Blind, Placebo Controlled, Four Way Crossover Study To Determine The Effects Of PF-03654764 +/- Allegra (Fexofenadine) On Symptoms Of Allergic Rhinitis In Subjects Exposed To Ragweed Pollen In An Environmental Exposure Unit.
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
- Pfizer
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Congestion scores
研究概览
简要总结
PF-03654764 should reduce the symptoms of allergic rhinitis. In this study patients will be exposed to pollen and their symptoms observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects 18-60 years allergic to ragweed pollen.
- •Subjects with appropriate symptom scores following exposure to ragweed in the environmental exposure unit.
排除标准
- •Subjects with significant diseases other than allergic rhinitis that may interfere with the safety or efficacy of PF-
- •Subjects with significant symptoms of allergic rhinitis within the 2 weeks prior to screening.
研究组 & 干预措施
PF-03654764 + Allegra
Experimental
干预措施: PF-03654764 (Drug)
PF-03654764 + Allegra
Experimental
干预措施: Allegra (Drug)
PF-03654764
Experimental
干预措施: PF-03654764 (Drug)
Allegra-D
Active Comparator
干预措施: Allegra-D (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Congestion scores
时间窗: 6 hours
Other allergic rhinitis symptoms
时间窗: 6 hours
次要结局
- Pharmacokinetics(6 hours)
- Blood pressure/pulse rate(6 hours)
- Adverse event reporting(2 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
早期 1 期
Study of a Topical Nasal Spray to Ease the Symptoms of HayfeverRhinitis, Allergic, SeasonalNCT01500629McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.21
已完成
3 期
Study to Find Out How Long it Takes Azelastine Hydrochloride 0.15% Nasal Spray to Relieve Symptoms in Patients Suffering From Allergic RhinitisAllergic RhinitisNCT04264637Bayer110
终止
4 期
Study of Nasonex® in Improving Sleep Disturbances Related to Perennial Allergic Rhinitis (Study P04909)(TERMINATED)Perennial Allergic RhinitisNCT00491374Schering-Plough
已完成
2 期
Intranasal SB-705498 in Allergic Rhinitis (AR) PatientsRhinitisNCT01424397GlaxoSmithKline70
已完成
4 期
Mometasone Furoate on Sleep Disturbances in Subjects With Seasonal Allergic Rhinitis (Study P04608) (COMPLETED)Seasonal Allergic RhinitisNCT00358527Organon and Co401