A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of 2 Doses of Aclidinium Bromide Compared With Placebo for 12 Weeks in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease Followed by a 40-Week Evaluation of the Higher Aclidinium Bromide Dose
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 544
- 试验地点
- 112
- 主要终点
- Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and tolerability of aclidinium bromide doses compared with placebo in the treatment of moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week run-in period followed by a 12-week double-blind, placebo-controlled treatment period. This will be followed by an open-label 40-week treatment period and a 2-week follow up phone call. All patients will receive the higher Aclidinium Bromide during the 40-week open label treatment period.
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, 2008; 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
1
Aclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks
干预措施: Aclidinium bromide (Drug)
2
Aclidinium bromide 400 μg dose twice per day, inhaled for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 400 μg will continue to receive open label 400µg aclidinium bromide for 40 weeks
干预措施: Aclidinium bromide (Drug)
3
Dose-match placebo, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on placebo will receive open label 400µg aclidinium bromide for 40 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1)
时间窗: Change from baseline (Week 0) to Week 12
Change from baseline in Trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)
Part B: Morning Predose (Trough) FEV1
时间窗: Change from baseline (Week 0) to 52 Weeks
Change from Baseline in Morning Pre-dose (trough) Forced Expiratory Volume in 1 Second (FEV1) at Week 52, Lost Observation Carried Forward (LOCF)
次要结局
- Part B: Peak FEV1(Change from baseline (Week 0) to 52 Weeks)
- Part A: Peak Forced Expiratory Volume in 1 Second (FEV1)(Change from baseline (Week 0) to Week 12)