NCT01591044已完成2 期
A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Doses of Inhaled R940343 in Patients With Mild to Moderate Allergic Asthma
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
- 301
- 试验地点
- 59
- 主要终点
- Change in FEV1
研究概览
简要总结
The purpose of this study is to determine the safety, efficacy and tolerability of R940343 in the treatment of mild to moderate asthma.
详细描述
The study is a multi-center, randomized, double-blind, placebo-controlled, parallel group study comparing 2 doses of inhaled R343 bid to placebo over 8 weeks in patients with mild to moderate allergic asthma. Patients who meet specific inclusion and exclusion criteria after an initial screening evaluation and a single-blind, run-in period will be randomized to receive either R343 or placebo.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical history of asthma
- •Ability to perform spirometry
排除标准
- •Chronic obstructive pulmonary disease or bronchiectasis
- •Upper or lower respiratory infection
研究组 & 干预措施
R940343 2mg, 2 puffs bid
Active Comparator
R343 2mg, 2 puffs bid
干预措施: R940343 2mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
R940343 1mg, 1 puff bid
Active Comparator
R343 1mg, 1 puff bid
干预措施: R940343 1mg (Drug)
结局指标
主要结局
Change in FEV1
时间窗: Baseline and Week 8
Change from baseline in pre-BD FEV1 (% predicted) at Week 8.
次要结局
未报告次要终点
研究者
研究点 (59)
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