A Non-controlled, Open Study for Assessing the Safety and Effectiveness of a Twice-daily FEX 60 mg - PE 10 mg (FEX60/PE10) Fixed Combination Tablet in Patients With Allergic Rhinitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Number of adverse events (Solicited AE reporting)
研究概览
简要总结
Primary Objective:
To assess the safety of twice-daily fexofenadine 60 mg/phenylephrine 10 mg (FEX60/PE10) combination tablet in patients with allergic rhinitis.
Secondary Objective:
To evaluate the effectiveness of a twice-daily FEX60/PE10 combination tablet on nasal symptoms (sneezing, rhinorrhea, and nasal congestion), and daily activity impairment.
详细描述
It will be 22 days at minimum and up to 32 days depending on screening, treatment, and post-treatment observation allowances.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 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
- 未提供
研究组 & 干预措施
FEX60/PE10
Internal use of FEX60/PE10 combination tablet will be administered twice daily (1 tablet per intake) for 2 weeks
干预措施: FEX60/PE10 (Drug)
结局指标
主要结局
Number of adverse events (Solicited AE reporting)
时间窗: From intake of FEX60/PE10 up to approximately 2 weeks
Changes from baseline in the nasal congestion score based on the patient's symptom diary
时间窗: After 2 weeks treatment
次要结局
- Change from baseline in the total score of 3 nasal symptoms (sneezing, rhinorrhea, and nasal congestion)(After 2 weeks treatment)
- Change in the total score of 3 nasal symptoms on a daily basis(After 2 weeks treatment)
- Change in the total score of 3 nasal symptoms during daytime(After 2 weeks treatment)
- Change in the total score of 3 nasal symptoms during night-time(After 2 weeks treatment)
- Change in the daily activity impairment score(After 2 weeks treatment)
- Change in the daily activity impairment score on a daily basis(After 2 weeks treatment)
- Change in the daily activity impairment score during daytime(After 2 weeks treatment)
- Change in the daily activity impairment score during night-time(After 2 weeks treatment)
- Change in nasal findings from baseline: color of inferior turbinate mucosa(After 2 weeks treatment)
- Change in nasal findings from baseline: congestion of inferior turbinate mucosa(After 2 weeks treatment)
- Change in nasal findings from baseline: consistency of discharge(After 2 weeks treatment)
- Assessment of patient's impression after treatment based on patient's symptom diary(After 2 weeks treatment)