Evaluation of Efficacy of Dellegra® Combination Tablet (Fexofenadine Hydrochloride 30mg /Pseudoephedrine Hydrochloride 60mg) in Allergic Rhinitis After Japanese Cedar Antigen Exposure in Japanese Population. Open Label Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Mean change in Total Nasal Symptom Score (sneezing, nasal discharge, nasal congestion, and itchy nose
研究概览
简要总结
Primary Objective:
To collect and analyze clinical data of Allergic Rhinitis patients' Total Nasal Symptom Score (TNSS) change after Dellegra internal use under high density pure Japanese cedar pollen exposure.
Secondary Objective:
To collect and analyze clinical data of Allergic Rhinitis patients' change in Total Symptom Score (TSS) and amount of nasal discharge, safety, and overall patients' impression about efficacy of Dellegra after Dellegra internal use under high density pure Japanese cedar pollen exposure.
详细描述
It will be 8 days at minimum and up to 17 days depending on screening visit 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
- 20 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 HCl
2 tablets of Dellegra Combination Tablets (Fexofenadine Hydrochloride 30 mg+Pseudoephedrine Hydrochloride 60 mg/tablet), oral, administrated 2 hours after start of exposure with 8,000 grains/cubic meter of Japanese cedar pollen
干预措施: Fexofenadine HCl 30 mg+Pseudophedrine HCl 60 mg (Drug)
结局指标
主要结局
Mean change in Total Nasal Symptom Score (sneezing, nasal discharge, nasal congestion, and itchy nose
时间窗: From 2 hours after antigen exposure (baseline) to 3 hours after intake of Dellegra
次要结局
- Mean change of Total Symptom Score (sneezing, nasal discharge, nasal congestion, itchy nose, lacrimation, and eye itching(Prior to exposure, and every 15 minutes for 5 hours after exposure start)
- Overall patients' impression about efficacy of Dellegra after Dellegra internal use (Score 1 [none] to 7 [very severe])(From intake of Dellegra up to 17 days)
- Number of patients who experienced adverse events(From intake of Dellegra up to 17 days)