NCT01382654已完成2 期
Two Formulations and Concentrations of Epinastine Nasal Spray Versus Azelastine Nasal Solution for Allergic Rhinitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 131
- 主要终点
- Overall preference rank at the completion of the study using the Overall Nasal Spray Evaluation Questionnaire (NSEQ)
研究概览
简要总结
The objectives of this study were to:
- Examine the tolerability of two formulations and two dose concentrations of epinastine.
- Select formulation(s) of epinastine for future studies by evaluating the individual sensory attribute scores of the Nasal Spray Evaluation Questionnaire (NSEQ) collected after each study drug administration and the subject preference ranking assessed at the completion of the study.
- Compare the preference of two formulations and two dose concentrations of epinastine compared to azelastine following a single dose of each in a randomized, double-blind, two-cohort, three-period crossover design.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between ages 18-70
- •history of SAR or PAR for 1 year
- •mild symptoms
排除标准
- •asthma or RAD
- •respiratory tract infection within 14 days prior to screening
研究组 & 干预措施
azelastine 0.1%
Active Comparator
nasal spray 2 sprays in each nostril for a total of 3 doses
干预措施: azelastine 0.1% (Drug)
epinastine 0.1%
Experimental
nasal spray 2 sprays to each nostril for a total of 3 doses
干预措施: epinastine 0.1% (Drug)
epinastine 0.1% with taste masking agent
Experimental
nasal spray 2 sprays to each nostril for a total of 3 doses
干预措施: epinastine 0.1% with taste masking agent (Drug)
epinastine 0.2%
Experimental
nasal spray 2 sprays to each nostril for a total of 3 doses
干预措施: epinastine 0.2% (Drug)
epinastine 0.2% with taste masking agent
Experimental
nasal spray 2 sprays to each nostril for a total of 3 doses
干预措施: epinastine 0.2% with taste masking agent (Drug)
结局指标
主要结局
Overall preference rank at the completion of the study using the Overall Nasal Spray Evaluation Questionnaire (NSEQ)
时间窗: 2 days
次要结局
- Scores from each individual response from the NSEQ of all administered formulations (two formulations and two concentrations of epinastine and azelastine).(2 days)
研究者
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