NCT02518139已完成3 期
A Phase 3, 52-week, Randomized, Active-Controlled Parallel Group Study to Evaluate the Safety and Tolerability of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mylan Inc.
- 入组人数
- 1,060
- 试验地点
- 1
- 主要终点
- Adverse Events: Frequency and Severity
研究概览
简要总结
The purpose of this study is to measure the safety and tolerability of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to tiotropium.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is a male or female subject 40 years of age or older
排除标准
- •Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study
研究组 & 干预措施
TD-4208-1
Experimental
88 mcg
干预措施: TD-4208 (Drug)
TD-4208-2
Experimental
175 mcg
干预措施: TD-4208 (Drug)
Tiotropium
Active Comparator
18 mcg
干预措施: Tiotropium (Drug)
结局指标
主要结局
Adverse Events: Frequency and Severity
时间窗: Baseline to Day 365
To assess the safety and tolerability of TD-4208 by assessing the frequency and severity of Treatment Emergent Adverse Events (TEAE)
次要结局
未报告次要终点
研究者
研究点 (1)
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