A Phase IIa Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Effects of Multiple Doses of Inhaled RNS60 and Budesonide on the Late Phase Asthmatic Response to Allergen Challenge in Patients With Mild Asthma. (This Study Has Been Amended to no Longer be a Cross Over Study; it Will be a Parallel (RNS60/Placebo) 1 Period Study and no Longer Involves the Administration of Budesonide)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in late asthmatic response (LAR) as measured by spirometry
研究概览
简要总结
The study will investigate the effect of treatment with RNS60 for 21 days. Subjects' FEV1 will be measured after an inhaled allergen challenge at baseline and again after 21 days of treatment.
详细描述
This is a randomized, placebo-controlled, parallel study in approximately 32 male and female subjects with mild asthma. Each subject will receive either the experimental or the placebo, administered as a nebulized dose twice daily for 21 days.
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
- 18 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
RNS60
RNS60, 4 ml twice daily
干预措施: RNS60 (Drug)
Placebo
Normal Saline, 4 ml twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change in late asthmatic response (LAR) as measured by spirometry
时间窗: Baseline and Day 21
The maximal percentage decrease from the pre-allergen challenge (post-diluent value) in FEV1 between 3 hours and 8 hours post-allergen challenge.
次要结局
未报告次要终点