A Multiple Dose, Double-blind, Double-dummy, Placebo Controlled, Parallel Clinical Trial to Assess the Efficacy and Safety of Twice Daily Inhaled Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 414
- 试验地点
- 22
- 主要终点
- Change From Baseline in Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment
研究概览
简要总结
The aim of the present study is to evaluate the 24h bronchodilatory efficacy of inhaled aclidinium bromide 400 µg administered twice a day versus placebo and tiotropium bromide, respectively, after 6 weeks of treatment.
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
- Double (Participant, 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
- •Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines).
- •Post-salbutamol (FEV1) < 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/FVC < 70%.
- •Current or ex-smokers of 10 ≥pack-years.
排除标准
- •Patients with no history or current diagnosis of asthma.
- •No evidence of an exacerbation within 6 weeks prior to the screening visit.
- •No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
- •No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
研究组 & 干预措施
Aclidinium bromide
Aclidinium bromide 400 µg administered twice per day during 6 weeks of treatment
干预措施: Aclidinium bromide (Drug)
Tiotropium
Tiotropium bromide 18 µg administered once per day during 6 weeks of treatment
干预措施: Tiotropium (Drug)
Placebo
Placebo comparator administered during 6 weeks of treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment
时间窗: Week 6
Change from baseline in normalised FEV1 area under the curve over the 24-h period immediately after morning Investigational Medicinal Product administration (AUC0-24h ) after 6 weeks on treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.
次要结局
- Change From Baseline in Normalised FEV1 Area Under the Curve Over the 12-h Night-time Period After 6 Weeks of Treatment(Week 6)