Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Mean Change in 2-week rTNSS From Baseline
研究概览
简要总结
The purpose of this study is to examine safety and efficacy of Patanase and Astelin in treating the symptoms of non-allergic vasomotor rhinitis (VMR).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of VMR with at least 2 years of chronic non-allergic rhinitis
- •Negative skin tests to a panel of allergens and positive histamine test within last 2 years
- •History of symptoms related to defined VMR triggers
排除标准
- •Nasal disorder, surgery, or concurrent disease that could interfere with evaluation of study medications
- •Bacterial or viral infection within 14 days of first visit. Diagnosis of acute sinusitis within 30 days of first visit
- •Chronic use of drugs that can cause rhinitis
研究组 & 干预措施
1
Olopatadine HCL Nasal Spray, 0.6%
干预措施: Olopatadine HCL (Patanase) Nasal Spray, 0.6% (Drug)
2
Azelastine HCl Nasal Spray, 137 mcg
干预措施: Azelastine HCl (Astelin) Nasal Spray, 137 mcg (Drug)
结局指标
主要结局
Mean Change in 2-week rTNSS From Baseline
时间窗: 2 week
Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.
次要结局
- Mean Change in Rhinorrhea Reflective Score(2 week)
- Mean Change Postnasal Drip Reflective Score(2 Weeks)
- Mean Change Nasal Congestion Reflective Score(2 Weeks)
- Mean Change in Sneezing Reflective Score(2 Weeks)