NCT02189577已完成2 期
A Multinational, Multicentre, Randomised, Double Blind, Placebo-Controlled, 2-way Crossover Study to Evaluate the Efficacy and Safety of Glycopyrrolate Bromide Administered Via pMDI (CHF 5259), for the Treatment of Patients 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
- 入组人数
- 100
- 试验地点
- 29
- 主要终点
- Change from baseline in pre-dose morning FEV1 on Day 28
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of CHF 5259 (glycopyrrolate bromide) for the treatment of COPD patients.
详细描述
A Multinational, Multicentre, Randomised, Double Blind, Placebo-Controlled, 2-way Crossover Study to Evaluate the Efficacy and Safety of Glycopyrrolate Bromide Administered Via pMDI (CHF 5259), for the Treatment of Patients With Chronic Obstructive Pulmonary Disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults (40 ≤ age ≤ 80 years) with a diagnosis of COPD
- •Current smokers or ex-smokers
- •A post-bronchodilator FEV1 < 60% of the predicted normal value and a post-bronchodilator FEV1/FVC < 0.7
- •Positive response to the reversibility test at screening defined as change in FEV1 ≥ 5%.
- •BDI score ≤ 10
- •Patients free of exacerbations for at least 1 month
排除标准
- •Pregnant or lactating women
- •Diagnosis of asthma
- •Patients treated for exacerbations in the 4 weeks prior to screening visit
- •Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as PRN
- •Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia
- •Known respiratory disorders other than COPD
- •Patients who have clinically significant cardiovascular condition
研究组 & 干预措施
CHF 5259
Experimental
CHF 5259
干预措施: CHF 5259 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in pre-dose morning FEV1 on Day 28
时间窗: Day 28
次要结局
- Change from baseline to day 28 in area under the curve for forced expiratory volume in 1 second measured at 11 timepoints between 0 to 12 hours postdose (FEV1 AUC0-12h)(Day 28)
研究者
研究点 (29)
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