A Long-Term, Randomized, Double-Blind Study of the Safety, Tolerability and Efficacy of Aclidinium Bromide At Two Dosage Levels When Administered to Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 605
- 试验地点
- 113
- 主要终点
- Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week rin-in period, a 52-week treatment period and a 2-week follow up phone call. All patients will be randomized to one of two doses of aclidinium bromide.
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
- Quadruple (Participant, Care Provider, 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 as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2010; postbronchodilator FEV1/FVC < 70%, and postbronchodilator FEV1 ≥ 30% and < 80% predicted
- •Current or former cigarette smokers
排除标准
- •Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit
- •Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1
- •Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness
- •History or presence of asthma verified from medical records
- •Chronic use of oxygen therapy greater than or equal to 15 hours per day
- •Patient with uncontrolled infection due to HIV and/or active hepatitis
- •Patients with a history of hypersensitivity reaction to inhaled anticholinergics
- •Patients with clinically significant cardiovascular conditions, including myocardial infarction during the previous 6 months, newly diagnosed arrhythmia within the previous 3 months, unstable angina, unstable arrhythmia that had required changes in pharmacological therapy or other intervention.
研究组 & 干预措施
Aclidinium Bromide 200 µg
aclidinium bromide, inhaled, 52 weeks of treatment
干预措施: Aclidinium Bromide 200 µg (Drug)
Aclidinium Bromide 400 µg
aclidinium bromide, inhaled, 52 weeks of treatment
干预措施: Aclidinium Bromide 400 µg (Drug)
结局指标
主要结局
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
时间窗: From baseline to 52 weeks
Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.
次要结局
- Change From Baseline in Peak FEV1(52 weeks)