NCT01636401已完成3 期
Efficacy and Safety of 400 μg Twice Daily of Aclidinium Bromide vs. Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家开始时间: 2012年8月最近更新:
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
- 试验地点
- 1
- 主要终点
- Change from baseline to Week 12 in morning predose (trough) FEV1
研究概览
简要总结
The purpose of this study was to observe the Efficacy and safety of 400 μg twice daily of aclidinium bromide vs. placebo when administered to patients with moderate to severe chronic obstructive pulmonary disease (COPD).
研究设计
- 研究类型
- Interventional
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
- •A diagnosis of stable moderate to severe COPD as defined by GOLD (the Global Initiative for Chronic Obstructive Lung Disease) guidelines(http://www.goldcopd.org); a postbronchodilator FEV1/forced vital capacity [FVC] ratio < 70% and FEV1 ≥ 30% to <80% of the predicted value.
- •Current or former cigarette smokers with a smoking history of at least 10 pack-years.
排除标准
- •History or current diagnosis of asthma
- •Patients who have been hospitalized for an acute COPD exacerbation within 3 months prior to Visit 1
- •Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks before Visit
- •Patients with any clinically significant respiratory conditions other than COPD
研究组 & 干预措施
aclidinium bromide
Active Comparator
干预措施: aclidinium bromide 400 μg (Drug)
Placebo
Placebo Comparator
干预措施: aclidinium bromide placebo (Drug)
结局指标
主要结局
Change from baseline to Week 12 in morning predose (trough) FEV1
时间窗: Week 12
次要结局
- Change from baseline to Week 12 in peak FEV1(Week 12)
研究者
研究点 (1)
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