14729-D9831C00002- 1 Month Biopsy Study (Biopsy)
2014年1月27日 更新者：AstraZeneca
A Double-blind, Placebo-controlled, Randomised, Parallel Group Phase IIa Study to Evaluate the Histological Changes, Cellularity, Clinical Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to study histological changes, cellularity, clinical efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease
研究概览
研究类型
介入性
注册 (实际的)
52
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。
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:
- Men or women 40 years or above
- FEV1 between 40 and 80% of predicted normal value post-bronchodilator
- Clinical diagnosis of COPD
Exclusion Criteria:
- Other clinically relevant disease or disorders
- Exacerbation of COPD within 30 days
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 |
|---|---|
|
安慰剂比较：安慰剂
|
安慰剂
|
|
实验性的：AZD1981
|
Oral tablet, twice daily, 4 weeks treatment
|
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 |
|---|---|---|
|
Aggregated Pathology Score
大体时间：Before and after 1 month treatment
|
Composite endpoint subscores: histological grade, immunohistochemistry grade, leucocyte counts.
Each subscore measured on scale 1 (normal) to 5 (worst outcome).
Composite score summed across the subscores, ranging from 3 (normal) to 15 (worst outcome).
Change from baseline.
|
Before and after 1 month treatment
|
|
Bronchoalveolar Lavage (BAL): Eosinophil Count (%)
大体时间：Before and after 1 month treatment
|
Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline
|
Before and after 1 month treatment
|
|
Bronchoalveolar Lavage (BAL): Neutrophil Count (%)
大体时间：Before and after 1 month treatment
|
Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline
|
Before and after 1 month treatment
|
|
Bronchoalveolar Lavage (BAL): Macrophages Count (%)
大体时间：Before and after 1 month treatment
|
Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline
|
Before and after 1 month treatment
|
|
Bronchoalveolar Lavage (BAL): Lymphocytes Count (%)
大体时间：Before and after 1 month treatment
|
Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline
|
Before and after 1 month treatment
|
|
Bronchoalveolar Lavage (BAL): Epithelial Cells Count (%)
大体时间：Before and after 1 month treatment
|
Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (% of total) from baseline
|
Before and after 1 month treatment
|
|
Bronchoalveolar Lavage (BAL): Total Cells Count
大体时间：Before and after 1 month treatment
|
Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline
|
Before and after 1 month treatment
|
|
Induced Sputum: Eosinophil Count (%)
大体时间：Before and after 3 week treatment
|
Change in Induced sputum Eosinophil count (% of total) from baseline
|
Before and after 3 week treatment
|
|
Induced Sputum: Neutrophils Count (%)
大体时间：Before and after 3 week treatment
|
Change in Induced sputum Neutrophils count (% of total) from baseline
|
Before and after 3 week treatment
|
|
Induced Sputum: Macrophages Count (%)
大体时间：Before and after 3 week treatment
|
Change in Induced sputum Macrophages count (% of total) from baseline
|
Before and after 3 week treatment
|
|
Induced Sputum: Lymphocytes Count (%)
大体时间：Before and after 3 week treatment
|
Change in Induced sputum Lymphocytes count (% of total) from baseline
|
Before and after 3 week treatment
|
|
Induced Sputum: Epithelial Cells Count (%)
大体时间：Before and after 3 week treatment
|
Change in Induced sputum Epithelial cells count (% of total) from baseline
|
Before and after 3 week treatment
|
|
Induced Sputum: Total Cells Count
大体时间：Before and after 3 week treatment
|
Change in Induced sputum Total cells count from baseline
|
Before and after 3 week treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1)
大体时间：Before and after 1 month treatment
|
Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to end of treatment
|
Before and after 1 month treatment
|
|
Clinical Chronic Obstructive Pulmonary Disease (COPD) The Clinical COPD Questionnaire (CCQ)
大体时间：Before and after 1 month treatment
|
Change in total CCQ score from baseline to last measurement on treatment.
scored on a scale of 0 - 6. 0 =(low symptoms)-6 =(high symptoms)
|
Before and after 1 month treatment
|
|
Peak Expiratory Flow (PEF) Morning
大体时间：Before and after 1 month treatment
|
Mean change in Peak Expiratory Flow (PEF) morning from baseline to the average of the treatment period
|
Before and after 1 month treatment
|
|
Peak Expiratory Flow (PEF) Evening
大体时间：Before and after 1 month treatment
|
Mean change in Peak Expiratory Flow (PEF) evening from baseline to the average of the treatment period
|
Before and after 1 month treatment
|
|
Chronic Obstructive Pulmonary Disease (COPD) Symptom Night-time Awakenings Score
大体时间：Before and after 1 month treatment
|
Mean change in COPD symptom night-time awakening score from baseline to the average of the treatment period.
0=(no symptom)-4=(no sleep)
|
Before and after 1 month treatment
|
|
Chronic Obstructive Pulmonary Disease (COPD) Symptom Breathing Score
大体时间：Before and after 1 month treatment
|
Mean change in COPD symptom breathing score from baseline to the average of the treatment period.
0= (none) - 4 =(severe).
|
Before and after 1 month treatment
|
|
Chronic Obstructive Pulmonary Disease (COPD) Symptom Cough Score
大体时间：Before and after 1 month treatment
|
Mean change in COPD symptom cough score from baseline to the average of the treatment period.
0= (none) - 4= (almost constant)
|
Before and after 1 month treatment
|
|
Chronic Obstructive Pulmonary Disease (COPD) Symptom Sputum Score
大体时间：Before and after 1 month treatment
|
Mean change in COPD symptom sputum score from baseline to the average of the treatment period.
0= (none) - 4= (severe).
|
Before and after 1 month treatment
|
|
Adverse Event (AE)
大体时间：1 month
|
Number of participants with an Adverse Event
|
1 month
|
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：Norbert Krug、Fraunhofer Institute
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。
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11月1日
研究完成 (实际的)
2009年6月1日
研究注册日期
首次提交
2008年10月3日
首先提交符合 QC 标准的
2008年10月3日
首次发布 (估计)
2008年10月6日
研究记录更新
最后更新发布 (估计)
2014年2月28日
上次提交的符合 QC 标准的更新
2014年1月27日
最后验证
2014年1月1日
更多信息
与本研究相关的术语
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.
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Universidad Autonoma de MadridCentro Universitario La Salle完全的