NCT03664882已完成3 期
Phase 3, Single-center, Sequential and Parallel-group, Double-blind, Randomized Study Evaluating the Efficacy and Safety of Fexofenadine Hydrochloride 180 mg (Allegra®/Telfast®) Versus Placebo in Subjects Suffering From Seasonal Allergic Rhinitis With Symptoms Aggravated in Presence of Pollutants
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Total nasal symptom score (TNSS)
研究概览
简要总结
Primary Objectives:
- To demonstrate that the aggravation of seasonal allergic rhinitis symptoms in the presence of pollutants is observed using an Environmental Exposure Unit.
- To evaluate the efficacy of fexofenadine hydrochloride in subjects suffering from seasonal allergic rhinitis symptoms aggravated in the presence of diesel exhaust particulates.
Secondary Objective:
To evaluate the safety of a single dose of fexofenadine hydrochloride 180 mg.
详细描述
The total study duration per subject is expected to last up to 4.5 months, depending on the timing of the screening visit.
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
- 18 Years 至 65 Years（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
- 未提供
研究组 & 干预措施
Fexofenadine
Experimental
Fexofenadine, single administration
干预措施: Fexofenadine M016455 (Drug)
Placebo
Placebo Comparator
Placebo, single administration
干预措施: Placebo (Drug)
结局指标
主要结局
Total nasal symptom score (TNSS)
时间窗: From hour 0 to hour 12 in Period 1 and Period 2
Assessed by measuring change in the area under the curve (AUC) of the TNSS during Period 1 and 2
TNSS
时间窗: From hour 2 to hour 12 in Period 3
Assessed by measuring change in the AUC of the TNSS from hour 2 (planned time of investigational medicinal product administration) to hour 12 in Period 3
次要结局
- Total symptom score (TSS)(From hour 2 to hour 12 in Period 3)
- Individual symptom score(From hour 2 to hour 12 in Period 3)
- TNSS(From hour 2 to hour 12 in Period 3)
- Adverse events(Up to 4.5 months)
研究者
研究点 (1)
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