NCT00435760已完成3 期
Single Dose, Double-blind, Double-dummy, 3 Period Cross-over, Placebo Controlled Clinical Trial to Assess the Reate of Onset of Action of Inhaled Aclidinium Bromide 200µg Compared to Placebo and Tiotropium 18µg in Patients With 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
- 115
- 试验地点
- 1
- 主要终点
- FEV1 Percentage Increase
研究概览
简要总结
This trial evaluates the rate of onset of bronchodilator action of aclidinium bromide compared to placebo and tiotropium in patients with severe COPD after a single dose treatment.
详细描述
This is a single dose, randomised, double-blind, double-dummy, 3 period cross-over, placebo controlled, multinational, multicentre trial.
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
- •Males and females aged ≥ 40 years
- •Current or ex-smokers of ≥ 10 pack-year
- •Clinical diagnosis of severe stable COPD
排除标准
- •History or current diagnosis of asthma, allergic rhinitis, or atopy
- •Respiratory tract infection or acute COPD exacerbation in the last 6 weeks
- •Hospitalised for an acute COPD exacerbation in the last 3 months
- •Evidence of contraindicated use of anticholinergic drugs
研究组 & 干预措施
Tiotropium
Active Comparator
1 puff, 1 day treatment
干预措施: Tiotropium (Drug)
Placebo
Placebo Comparator
Tiotropium or Aclidinium Placebo, 1 day treatment
干预措施: Placebo Tiotropium (Drug)
Placebo
Placebo Comparator
Tiotropium or Aclidinium Placebo, 1 day treatment
干预措施: Placebo LAS34273 (Drug)
Aclidinium bromide
Experimental
200 micrograms, once daily, 1 day treatment
干预措施: Aclidinium bromide (Drug)
结局指标
主要结局
FEV1 Percentage Increase
时间窗: 30 minutes
Percentage of patients achieving a FEV1 increase from baseline equal to or greater than 10% at 30 minutes
次要结局
- Normalised Area FEV1 AUC 0-3h(0-3 hours)
研究者
研究点 (1)
Loading locations...
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