A Long-term, Randomized, Double-blind Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide at Two Dose Levels When Administered to Patients With Moderate to Severe 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
- 291
- 试验地点
- 83
- 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 extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week lead-in study. All patients will be randomized from the lead-in study at one of two doses of aclidinium.
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
- •Completion of a lead-in study (NCT00891462)
排除标准
- •Use or anticipated use of any medication prohibited in this study
- •Evidence of abnormal clinical laboratory values, vital signs, or electrocardiographic (ECG) results or the presence of abnormities in physical examination findings
- •The presence of anti-cholinergic effects (eg, dry mouth, urinary retention, narrow angle glaucoma)
- •QTcB of >500 msec on both the pre-dose and post-dose ECG
- •Women who are pregnant, intend to become pregnant, or are breast-feeding
- •A life expectancy of less than 1 year
- •Noncompliance with IP dosing and/or attending clinic visits during the lead-in study
- •Significant interruption of double-blind therapy during the transition from the lead-in study into the extension study.
研究组 & 干预措施
1
Aclidinium bromide dose, inhaled, for 52 weeks of treatment
干预措施: Aclidinium bromide (Drug)
2
Aclidinium bromide dose, inhaled, for 52 weeks of treatment
干预措施: Aclidinium bromide (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: Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks
Change From Baseline (Visit 2 of lead-in Study NCT00891462, \[LAS-MD-33\]) to Week 52 (Week 64 From Start of NCT00891462, \[LAS-MD-33\]) in Morning Predose (Trough) FEV1
次要结局
- Change From Baseline in Peak FEV1(52 weeks)