The Evaluation of Singulair for the Treatment of Non-Allergic Rhinitis Eosinophil Syndrome (NARES)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Determine whether montelukast is more effective than placebo at reducing the number of nasal eosinophils associated with NARES
研究概览
简要总结
The purpose of this trial is to determine if patients with NARES treated with montelukast (Singulair) will have improved nasal symptom scores and reduced nasal eosinophils.
详细描述
Patients will receive either montelukast or placebo in the treatment of NARES. 4 visits will be conducted over 12 weeks. A history and physical will be performed at the beginning of the trial and at the end. Skin testing will be done at Visit 1. Nasal smears and lavages will be performed at every visit. Patients will be compensated for time and travel.
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 (Investigator, Outcomes Assessor)
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
- •Aged 18 - 65 years
- •Diagnosed with NARES
排除标准
- •Smokers, exposed to passive smoke
- •Diagnosis of seasonal allergic rhinitis (SAR), perennial allergic rhinitis (PAR), or vasomotor rhinitis (VMR)
研究组 & 干预措施
1
montelukast
干预措施: montelukast (Drug)
2
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Determine whether montelukast is more effective than placebo at reducing the number of nasal eosinophils associated with NARES
时间窗: December 2008
Determine whether montelukast is more effective than placebo at reducing nasal symptom scores
时间窗: December 2008
次要结局
未报告次要终点