Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (TOP)
2010年11月4日 更新者：AstraZeneca
A 4-week Double-blind, Placebo-controlled, Randomized, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.
研究概览
研究类型
介入性
注册 (实际的)
65
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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Hvidovre、丹麦
- Research Site
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København Nv、丹麦
- Research Site
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Odense C、丹麦
- Research Site
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Elverum、挪威
- Research Site
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Oslo、挪威
- Research Site
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Trondheim、挪威
- Research Site
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Lund、瑞典
- Research Site
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Helsinki、芬兰
- Research Site
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Preitilä、芬兰
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Tampere、芬兰
- Research Site
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Breda、荷兰
- Research Site
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Groningen、荷兰
- Research Site
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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 及以上 (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:
- Clinical diagnosis of COPD, with symptoms for more than 1 year
- Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack-year=20 cigarettes/day for 1 year)
- Lung function (FEV1) 40 to 80% of the predicted normal value after using a short acting bronchodilator
Exclusion Criteria:
- Clinical suspicion of active tuberculosis
- Any current clinically significant respiratory tract disorder other than COPD
- History of current clinically relevant arrhythmia, heart block, ECG abnormalities, or unstable angina
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：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：2个
安慰剂
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实验性的：1个
AZD4818
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Dry Powder, inhalation, b.i.d., 4 weeks
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Patients Experiencing Adverse Events
大体时间：At all study visits
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Number of patients who had an Adverse Event
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At all study visits
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Forced Expiratory Volume 1 (FEV1)
大体时间：Before treatment and after 1, 2, 3 and 4 weeks of treatment
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Change in (FEV1) from baseline to end of treatment
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Before treatment and after 1, 2, 3 and 4 weeks of treatment
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Forced Vital Capacity (FVC)
大体时间：Before treatment and after 1, 2, 3 and 4 weeks of treatment
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Change in FVC from baseline to end of treatment
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Before treatment and after 1, 2, 3 and 4 weeks of treatment
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Vital Capacity (VC)
大体时间：Before treatment and after 1, 2, 3 and 4 weeks of treatment
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Change in VC from baseline to end of treatment
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Before treatment and after 1, 2, 3 and 4 weeks of treatment
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Inspiratory Capacity (IC)
大体时间：Before treatment and after 1, 2, 3 and 4 weeks of treatment
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Change from IC baseline to end of treatment
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Before treatment and after 1, 2, 3 and 4 weeks of treatment
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Forced Expiratory Flow (FEF) 25%-75%
大体时间：Before treatment and after 1, 2, 3 and 4 weeks of treatment
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Change in FEF from baseline to end of treatment
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Before treatment and after 1, 2, 3 and 4 weeks of treatment
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Peak Expiratory Flow (PEF) Morning
大体时间：Daily during run-in and treatment
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Change from average during run-in to average during treatment
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Daily during run-in and treatment
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Peak Expiratory Flow (PEF) Evening
大体时间：Daily during run-in and treatment
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Change in PEF from average during run-in to average during treatment
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Daily during run-in and treatment
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The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total
大体时间：Before treatment and after 1, 2, 3 and 4 weeks of treatment
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Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)
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Before treatment and after 1, 2, 3 and 4 weeks of treatment
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Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness
大体时间：Daily during run-in and treatment
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Change from average during run-in to average during treatment.
Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
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Daily during run-in and treatment
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Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness
大体时间：Daily during run-in and treatment
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Change from average during run-in to average during treatment.
Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
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Daily during run-in and treatment
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Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score
大体时间：Daily during run-in and treatment
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Change from average during run-in to average during treatment.
Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
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Daily during run-in and treatment
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Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score
大体时间：Daily during run-in and treatment
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Change from average during run-in to average during treatmentScores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
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Daily during run-in and treatment
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6-minute Walk Test
大体时间：Before treatment and after 4 weeks of treatment
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Change from baseline to end of treatment
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Before treatment and after 4 weeks of treatment
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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
调查人员
- 首席研究员：Huib AM Kerstjens, MD, PhD、University Medical Centre, Groningen, The Netherlands
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
2008年1月1日
初级完成 (实际的)
2008年6月1日
研究完成 (实际的)
2008年8月1日
研究注册日期
首次提交
2008年2月25日
首先提交符合 QC 标准的
2008年2月25日
首次发布 (估计)
2008年3月5日
研究记录更新
最后更新发布 (估计)
2010年12月6日
上次提交的符合 QC 标准的更新
2010年11月4日
最后验证
2010年11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.