A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 6-Week Clinical Study to Assess the Effect of Inhaled Aclidinium Bromide (LAS34273) 200 ug on Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe COPD
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 181
- 试验地点
- 52
- 主要终点
- Change From Baseline in Exercise Endurance Time (ET)
研究概览
简要总结
This study evaluated the effect of inhaled aclidinium bromide on exercise endurance and in reducing resting and dynamic lung hyperinflation in patients with moderate to severe COPD. It was 9 weeks in duration, consisting of; a 2-week run-in period, 6 weeks of double-blind treatment, and a 1-week follow-up phone call. All patients meeting the eligibility criteria were randomized to one of two treatment groups: aclidinium bromide or placebo.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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 (GOLD 2006); post-levalbuterol FEV1 >=30% and < 80% predicted and FEV1/FVC<70% predicted
- •Current or former cigarette smoker
- •Functional Residual Capacity (FRC) measured by body plethysmography >= 120% of predicted value
- •Baseline Dyspnea Index (BDI) focal score ≤ 7 at Visit 4
排除标准
- •History of presence of asthma, allergic rhinitis, or atopy
- •Hospitalization for acute COPD exacerbation in the 3 months prior to study entry
- •Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry
- •Clinically significant respiratory conditions other than COPD
- •Chronic use of oxygen therapy >= 15 hours a day
研究组 & 干预措施
Aclidinium
干预措施: Aclidinium Bromide (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Exercise Endurance Time (ET)
时间窗: From baseline Week 0 (Visit 4) to Week 6 (Visit 6)
Exercise endurance time is defined as the time from the increase in work rate at 75% Wmax (watts) to the point of symptom limitation. The Wmax is defined as the highest work rate the patients were able to maintain for at least 30 seconds.
次要结局
- Trough Forced Expiratory Volume in 1 Second (FEV1)(Change from baseline (Visit 4) at Week 6 (Visit 6))
- Trough Inspiratory Capacity (IC)(Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6))
- Functional Residual Capacity (FRC)(Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6))
- Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio(Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6))