Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo (LAC-MD-27)
2017年1月16日 更新者：AstraZeneca
Efficacy and Safety Study of Two Fixed-Dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate, and Placebo All Administered Twice Daily (BID) to Patients With Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to evaluate the efficacy of this multicenter, randomized, double-blind, placebo-controlled, 4-period, incomplete-block crossover, dose-ranging study comparing 2 fixed dose combinations (FDCs) of aclidinium bromide with formoterol fumarate or with placebo, aclidinium bromide and formoterol fumarate, all administered twice a day (BID) in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD) beginning with a 2-week run-in period and with a 7-10 day washout each between treatment period.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
128
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Arizona
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Glendale、Arizona、美国、85306
- Forest Investigative Site 0909
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Pheonix、Arizona、美国、85006
- Forest Investigative Site 2050
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California
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Rancho Mirage、California、美国、92270
- Forest Investigative Site 2029
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Stockton、California、美国、95207
- Forest Investigative Site 1084
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Colorado
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Wheat Ridge、Colorado、美国、80033
- Forest Investigative Site 2045
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Florida
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Clearwater、Florida、美国、33765
- Forest Investigative Site 1152
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Tampa、Florida、美国、33603
- Forest Investigative Site 2053
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Tampa、Florida、美国、33613
- Forest Investigative Site 2047
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Massachusetts
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N. Dartmouth、Massachusetts、美国、02747
- Forest Investigative Site 1431
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New Jersey
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Summit、New Jersey、美国、07901
- Forest Investigative Site 2084
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New York
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Elmira、New York、美国、14901
- Forest Investigative Site 1119
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North Carolina
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Elizabeth city、North Carolina、美国、27909
- Forest Investigative Site 2035
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Raleigh、North Carolina、美国、27607
- Forest Investigative Site 1153
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Ohio
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Cincinnati、Ohio、美国、45242
- Forest Investigative Site 2028
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Oregon
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Medford、Oregon、美国、97504
- Forest Investigative Site 2043
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Portland、Oregon、美国、97213
- Forest Investigative Site 1106
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Rhode Island
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E. Providence、Rhode Island、美国、02914
- Forest Investigative Site 1089
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South Carolina
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Spartanburg、South Carolina、美国、29303
- Forest Investigative Site 1121
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Texas
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San Antonio、Texas、美国、78215
- Forest Investigative Site 1498
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Waco、Texas、美国、76712
- Forest Investigative Site 1129
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Understand the study procedures and be willing to participate in the study as indicated by signing the ICF and HIPAA form
- Be male or female aged 40 to 80 years, inclusive
- Have a diagnosis of stable, moderate to severe COPD (stages II and III) as defined by guidelines of the Global Initiative for Chronic Obstructive Lung Disease (2008)
- Be a current or former cigarette smoker with a smoking history of at least 10 pack-years
- Have post-albuterol/salbutamol FEV1 values ≥ 30% and < 80% of the predicted value. FEV1 will be measured at the Screening Visit (Visit 1) between 10 and 15 minutes after inhalation of albuterol/salbutamol.
- Have post-albuterol/salbutamol FEV1/FVC values < 70% (ie, 100 × post- albuterol/salbutamol FEV1/FVC < 70%).
- If female, be at least 1 year postmenopausal or surgically sterile (defined as having a hysterectomy or tubal ligation). Women of childbearing potential must have a negative serum β-human chorionic gonadotropin pregnancy test at screening
- Be in good stable health (as judged by the Investigator) other than the COPD, based on medical history, physical examination, ECG, spirometry, and clinical laboratory data evaluations
- Have COPD symptoms and FEV1 values at the time of randomization that are stable compared with those at Screening (Visit 1), according to the Investigator's medical judgment
Exclusion Criteria:
- Have been hospitalized for an acute COPD exacerbation within 3 months before screening
- Have any respiratory tract infection (including the upper respiratory tract) or signs of a COPD exacerbation or respiratory infection in the 6 weeks before Screening (Visit 1).
- Have any clinically significant respiratory conditions other than COPD
- Have a history or presence of asthma verified from medical records
- Have used theophylline (including long-acting theophylline) within the previous 3 months before study entry
- Have Stage II hypertension, defined as systolic pressure of 160 and above, and diastolic pressure of 100 and above
- Chronic use of oxygen therapy ≥ 15 hours a day
- Have a history, current diagnosis, or presence of exercise-induced bronchospasm
- Have a body mass index ≥ 40 kg/m2
- Have participated in an pulmonary rehabilitation program within the previous 3 months
- Have clinically significant cardiovascular conditions
- Have uncontrolled infection resulting from human immunodeficiency virus and/or active hepatitis
- Have symptomatic prostatic hypertrophy and/or bladder neck obstruction.
- Have narrow-angle glaucoma
- Have a history of hypersensitivity reaction (including report of paradoxical bronchospasm) to inhaled anticholinergics (including aclidinium bromide), β2 adrenergic agonists, or any other inhaled medication or any component thereof
- Have a QTcB, as indicated in the centralized reading report, above 470 msec in the resting ECGs performed at Screening (Visit 1) and/or patients who are using medications that may prolong the QT interval
- Have clinically relevant abnormalities in the results of clinical laboratory tests, in ECG parameters other than QTc, in results of the physical examination,
- Have any concurrent medical condition that, in the judgment of the Investigator, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient's well-being
- Do not maintain regular day/night, waking/sleeping cycles (eg, patients with history of sleep apnea syndrome or any disease related with sleep disturbances such as restless legs syndrome or somnambulism)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Aclidinium 400 μg / Formoterol 12 μg
Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)
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Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.
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实验性的：Aclidinium 400 μg / formoterol 6 μg
Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)
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Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.
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实验性的：Aclidinium 400 μg
Aclidinium bromide 400 μg administered twice-daily (BID)
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Aclidinium bromide 400 μg administered twice-daily (BID) for a 14 day period within four different treatment periods.
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有源比较器：Formoterol 12 μg
Formoterol fumarate 12 μg twice-daily
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Formoterol fumarate 12 μg twice-daily for a 14 day period within four different treatment periods.
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安慰剂比较：Placebo
Placebo twice-daily
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Placebo twice-daily delivered by inhalation for a 14 day period within four different treatment periods.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12)
大体时间：0 to 12 hours post-dose on Day 14
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0 to 12 hours post-dose on Day 14
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
大体时间：Day 14
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Day 14
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Change From Baseline in Morning Peak Forced Expiratory Volume in One Second (FEV1)
大体时间：Day 14
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Day 14
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年12月1日
初级完成 (实际的)
2010年8月1日
研究完成 (实际的)
2010年8月1日
研究注册日期
首次提交
2010年1月13日
首先提交符合 QC 标准的
2010年1月13日
首次发布 (估计)
2010年1月14日
研究记录更新
最后更新发布 (实际的)
2017年2月28日
上次提交的符合 QC 标准的更新
2017年1月16日
最后验证
2017年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.