NCT01471171已完成3 期
A Multiple Dose, Randomised, Double-blind, Placebo Controlled, 2 Period Crossover Clinical Trial to Assess the Effect of Aclidinium Bromide 400 μg BID on Exercise Endurance in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
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
- AstraZeneca
- 入组人数
- 112
- 试验地点
- 10
- 主要终点
- Change From Baseline in Endurance Time (Seconds)
研究概览
简要总结
The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg twice a day (BID) administered twice a day versus placebo on exercise endurance and on hyperinflation and dyspnoea at rest and during exercise after 3 weeks of treatment.
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
- 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 (Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines).
- •Post-salbutamol Forced Expiratory Volume in one second(FEV1) < 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/Forced Vital Capacity (FVC) < 70%.
- •Current or ex-smokers of ≥ 10 pack-years
- •Functional residual capacity (FRC) measured by body plethysmography at Screening Visit ≥ 120% of predicted value
排除标准
- •History or current diagnosis of asthma
- •Signs of an exacerbation within 6 weeks ( or 3 months if results in hospitalisation) prior to the screening visit or during the run-in period.
- •Clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
- •Conditions where the use of anticholinergic drugs is contraindicated, such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
- •Patients with an oxygen saturation < 85% during cycle exercise on room air at Screening Visit, Run- in Visit and Visit
- •Contra-indications of cardiopulmonary exercise testing.
- •Patient who in the investigator's opinion will need to start a pulmonary rehabilitation program during the study and/or patients who have just started/finished pulmonary rehabilitation at least 3 months prior to the Screening Visit.
研究组 & 干预措施
Aclidinium bromide
Experimental
3-week treatment periods
干预措施: Aclidinium Bromide (Drug)
Placebo
Experimental
3-week treatment periods
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Endurance Time (Seconds)
时间窗: Week 3
Change from baseline in endurance time during constant work rate cycle ergometry to symptom limitation at 75% of Maximum Work load (Wmax) after 3 weeks of treatment.
次要结局
- Change From Baseline in Trough Inspiratory Capacity (IC) (Litres)(Week 3)
- Change From Baseline in Intensity of Dyspnoea(Week 3)
研究者
研究点 (10)
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