A Study to Investigate the Bronchodilatory Effect of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
2016年8月2日 更新者：Novartis
A Randomized, Double-blind, Placebo-controlled, Multi-center, Two-period Crossover Study to Investigate the Bronchodilatory Effect of 50 µg NVA237 Inhaled Once Daily in Patient With Chronic Obstructive Pulmonary Disease (COPD).
This study was intended to assess how well inhaled NVA237 opens up the airways of patients with mild, moderate or severe COPD over a 24 hour period after a 14 day treatment period.
研究概览
研究类型
介入性
注册 (实际的)
33
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:
- Male or female aged greater than 40 years with COPD Current or ex-smokers
Exclusion Criteria:
- Cardiac (heart) disorders, history of asthma, requiring oxygen therapy. Other protocol-defined inclusion/exclusion criteria may apply
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Placebo then NVA237 50μg
Placebo 50 μg capsules followed by NVA237 50 μg capsules for inhalation once daily with Concept 1 device.
|
Matching placebo capsules were supplied for inhalation once daily with Concept 1 device.
NVA237 50 μg capsules were supplied for inhalation once daily with Concept 1 device.
|
|
实验性的：NVA237 50μg then placebo
NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device.
|
Matching placebo capsules were supplied for inhalation once daily with Concept 1 device.
NVA237 50 μg capsules were supplied for inhalation once daily with Concept 1 device.
|
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 |
|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14
大体时间：From Day 1 to 0-24 hours after drug administration on Day 14
|
Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.
This outcome measures the change is FEV1 from predose (day 1) to the readings taken 0-24 hours post dose on day 14.
The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.
|
From Day 1 to 0-24 hours after drug administration on Day 14
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1) AUC 0-12 Hours on Day 14
大体时间：From day 1 to 0 -12 hours after drug administration on Day 14
|
Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.
This outcome measures the change is FEV1 from pre-dose (day 1) to the readings taken 0-12 hours post dose on day 14.
The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.
|
From day 1 to 0 -12 hours after drug administration on Day 14
|
|
Forced Expiratory Volume in One Second (FEV1) AUC 12-24 Hours on Day 14
大体时间：From Day 1 to 12 hours-24 hours after drug administration on Day 14
|
Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.
This outcome measures the change is FEV1 from pre-dose (day 1) to the readings taken 12-24 hours post dose on day 14.
The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.
|
From Day 1 to 12 hours-24 hours after drug administration on Day 14
|
|
Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs)
大体时间：Day 14
|
According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening , causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above.
See Adverse Events module for details.
|
Day 14
|
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
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2月1日
初级完成 (实际的)
2009年5月1日
研究完成 (实际的)
2009年5月1日
研究注册日期
首次提交
2009年3月4日
首先提交符合 QC 标准的
2009年3月4日
首次发布 (估计)
2009年3月5日
研究记录更新
最后更新发布 (估计)
2016年9月14日
上次提交的符合 QC 标准的更新
2016年8月2日
最后验证
2011年6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.
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Mila (bMotion Technologies)完全的
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