Research to Evaluate a Possible Relation Between Values Obtained After Processing CT Images, Lung Function Tests and the Experience of the Patient During an Exacerbation in COPD Patients.
2014年11月26日 更新者：FLUIDDA nv
Correlation of Functional Respiratory Imaging Parameters With Lung Function Parameters and Patient Reported Outcome Measures During Exacerbation of COPD.
In this study the consequences of exacerbations will be visualized by high resolution computed tomography (HRCT) scan at functional residual capacity (FRC) and total lung capacity (TLC) as taken during an episode of exacerbation and after recovering.
Changes in HRCT based airway dimensions and computational fluid dynamic (CFD) -based resistance values will be correlated with changes in patient reported outcomes (PROs) and lung function tests recorded at the same time.
研究概览
研究类型
介入性
注册 (实际的)
53
阶段
- 不适用
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, ≥ 40 years old
- COPD as defined by the global Initiative on obstructive lung disease4
- Post-bronchodilator FEV1/FVC < 70% AND post-bronchodilator FEV1 <80%pred as documented in the last 5 years.
- Smoking history of at least 10 pack-years
- At entry in the study experiencing an exacerbation defined as an acute change in the patient 's baseline dyspnea, cough, and/or sputum that is beyond normal day to day variations, and that necessitates the administration or doubling of systemic corticosteroid treatment.
- Patients must be able to understand and complete protocol requirements, instructions, questionnaires and protocol-stated restrictions.
- Written and signed informed consent
Exclusion Criteria:
- Pregnant or lactating females
- Patient diagnosed with asthma
- Patient with pneumonia as defined radiologically at the start of the exacerbation
- Patient with a history of or presence of lung cancer
- Patient with an indication for non-invasive ventilation
- Patient unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
- Patient who received any investigational new drug within the last 4 weeks prior to visit 1.
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：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：No treatment
CT-scans will be taken in the study.
The EC of the University hospital antwerp considers this as an intervention.
|
HRCT scan at FRC and TLC as taken during an episode of exacerbation and after recovering.
其他名称：
|
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 |
|---|---|---|
|
Changes in functional respiratory imaging parameters
大体时间：Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
|
The primary objective of this study is to evaluate whether changes in HRCT based airway dimensions and Computational Fluid Dynamic (CFD)-based resistance values correlate with changes in lung function parameters, under the conditions of exacerbation of COPD as well as after recovering from exacerbation.
|
Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
|
|
Changes in lung function parameters
大体时间：Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
|
The primary objective of this study is to evaluate whether changes in HRCT based airway dimensions and Computational Fluid Dynamic (CFD)-based resistance values correlate with changes in lung function parameters, under the conditions of exacerbation of COPD as well as after recovering from exacerbation.
|
Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in patient reported outcome (PRO) measures
大体时间：Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
|
The secondary objective is to check if the changes in CFD data actually correlate better with changes in PRO than changes in lung function parameters.
|
Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Reproducibility of segmentation
大体时间：Within 1 month of visit
|
As tertiary objective the reproducibility of the segmentations done by the centers will be evaluated.
To accomplish reproducible segmentations the multiple centers will be guided to perform accurate segmentations, and bottlenecks in the usage of the program will be identified and resolved in order to simplify it where necessary and possible.
|
Within 1 month of visit
|
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、University Medical Center Groningen
- 首席研究员：Emiel FM Wouters, MD、Maastricht University Medical Center
- 首席研究员：Massimo Pistolesi, MD、University of Florence
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
2012年9月1日
初级完成 (实际的)
2014年9月1日
研究完成 (实际的)
2014年9月1日
研究注册日期
首次提交
2012年9月6日
首先提交符合 QC 标准的
2012年9月10日
首次发布 (估计)
2012年9月13日
研究记录更新
最后更新发布 (估计)
2014年12月2日
上次提交的符合 QC 标准的更新
2014年11月26日
最后验证
2014年11月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- FLUI-2011-79
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.