A Phase III, Long-term, Randomized, Double-blind, Extension Study of the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28- Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 921
- 试验地点
- 208
- 主要终点
- Percentage of Patients to Experience Any Treatment-emergent Adverse Event
研究概览
简要总结
The purpose of this Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and health-related quality of life assessments will also be evaluated. This extension study will include a 28 week treatment period, followed by a four week follow up visit. All patients will remain in the same treatment group as for the lead-in study and continue on one of the four treatment arms 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
- 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 the treatment phase of the lead-in study, LAC-MD-31
- •Written informed consent obtained from the patient before the initiation of any study specific procedures
- •No medical contraindication as judged by the PI
- •Compliance with LAC-MD-31 study procedures and IP dosing.
排除标准
- •No specific exclusion criteria
研究组 & 干预措施
1
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose
干预措施: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) (Drug)
2
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose
干预措施: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) (Drug)
3
Aclidinium bromide 400 μg
干预措施: Aclidinium bromide (Drug)
4
Formoterol Fumarate 12 μg
干预措施: Formoterol Fumarate (Drug)
5
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Patients to Experience Any Treatment-emergent Adverse Event
时间窗: Baseline of lead-in study to follow-up call 14±3 days after last dose of investigational product (up to Week 52)
For each safety parameter, the last assessment made before the first dose of investigational product in the lead-in study (LAC MD-31) was used as the baseline for all analyses of that safety parameter in this extension study
次要结局
- Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Clinical Laboratory Values for Hematology, Chemistry or Urinalysis(Baseline of lead-in study to end of treatment (up to Week 52))
- Percentage of Patients to Experience a Potentially Significant Post-baseline 12-lead ECG Value(Baseline of lead-in study to end of treatment (up to Week 52))
- Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Vital Signs (Pulse Rate, Systolic or Diastolic Blood Pressure or Weight)(Baseline of lead-in study to end of treatment (up to Week 52))