NCT00363896已完成3 期
Clinical Trial Assessing Efficacy and Safety of LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
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
- 843
- 试验地点
- 131
- 主要终点
- Trough FEV1 (L) at 28 Weeks on Treatment
研究概览
简要总结
To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.
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
- Double (Participant, Investigator)
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
- •Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable COPD
排除标准
- •History or current diagnosis of asthma, recent respiratory tract infection or acute COPD exacerbation, life expectancy of less than 1 year, known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo once-daily via inhalation
干预措施: Placebo (Drug)
Aclidinium 200 μg once-daily
Experimental
Aclidinium bromide 200 μg once-daily by inhalation
干预措施: Aclidinium bromide (Drug)
结局指标
主要结局
Trough FEV1 (L) at 28 Weeks on Treatment
时间窗: Week 28
Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 28 weeks
Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment
时间窗: Week 12
Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 12 weeks
次要结局
- Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment(Week 52)
- Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment(52 weeks)
研究者
研究点 (131)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)Chronic Obstructive Pulmonary Disease (COPD)NCT00358436AstraZeneca804
终止
3 期
Efficacy and Safety Study of ALS-L1023 in Patients With Abdominal Obesity of Metabolic SyndromeAbdominal Obesity Metabolic SyndromeNCT01872182Hanmi Pharmaceutical Company Limited200
终止
2 期
A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusNCT05123586Eli Lilly and Company85
已完成
2 期
A Study to Evaluate the Efficacy and Safety of ALS-L1023 in Subjects With NASHNonalcoholic SteatohepatitisNCT04342793AngioLab, Inc.60
终止
2 期
Efficacy and Safety of Lu AA34893 in Patients With Bipolar DepressionDepression in Patients With Bipolar DisorderNCT00622245H. Lundbeck A/S166