NCT00891462已完成3 期
Efficacy and Safety of Aclidinium Bromide at Two Dose Levels (200 μg Twice Daily, 400 μg Twice Daily) vs. Placebo When Administered to Patients With 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
- 561
- 试验地点
- 1
- 主要终点
- Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
研究概览
简要总结
The purpose of this study is to assess the efficacy (effectiveness) and safety of aclidinium bromide doses as compared to placebo in the treatment of moderate to severe chronic obstructive pulmonary disease. The study will be 16 weeks in duration; 2-week run-in period, 12-week double-blind treatment, and 2-week follow-up phone visit.
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, 2009; 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
Experimental
Aclidinium bromide dose, inhaled, for 12 weeks of treatment
干预措施: Aclidinium bromide (Drug)
2
Experimental
Aclidinium bromide dose, inhaled, for 12 weeks of treatment
干预措施: Aclidinium bromide (Drug)
3
Placebo Comparator
Inhaled placebo for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
时间窗: Change from Baseline to 12 weeks
Change from baseline in trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)
次要结局
- Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1)(Change from Baseline to 12 weeks)
研究者
研究点 (1)
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