NCT02040792已完成2 期
A Phase 2B, 28-Day, Randomized, Double-Blind Placebo-Controlled Parallel Group Study 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
- 2 期
- 状态
- 已完成
- 发起方
- Mylan Inc.
- 入组人数
- 355
- 试验地点
- 1
- 主要终点
- Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second)
研究概览
简要总结
This study evaluated the safety and efficacy of four doses of TD-4208 and a placebo product when administered once daily for 28 days using a jet nebulizer to patients with moderate to severe chronic obstructive pulmonary disease.
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
- 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
- •Subject must have a negative pregnancy test, and must be prepared to use effective contraception if of child-bearing potential
- •Subject is capable of performing reproducible spirometry maneuvers
- •Subject has post-bronchodilator FEV1/FVC ratio <0.7
- •Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the GOLD Guidelines)
- •Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80% of predicted normal
- •Subject has a current or past smoking history of at least 10 pack-years.
排除标准
- •Subject has a significant respiratory disease or disorder other than COPD that would affect the interpretation of data from this study
- •Subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergic or beta-agonist agents
- •Subject suffers from any medical condition that would preclude the use of inhaled anticholinergic agents
- •Subject has been hospitalized for COPD or pneumonia within 12 weeks
- •Subject requires long-term oxygen therapy (>15 hours a day)
研究组 & 干预措施
350 mcg
Experimental
TD-4208
干预措施: TD-4208 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
44 mcg
Experimental
TD-4208
干预措施: TD-4208 (Drug)
88 mcg
Experimental
TD-4208
干预措施: TD-4208 (Drug)
175 mcg
Experimental
TD-4208
干预措施: TD-4208 (Drug)
结局指标
主要结局
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second)
时间窗: Baseline to 28 days
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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