LCI and Bronchial Inflammation in Patients With BO (FRABO-02)
2015年7月22日 更新者：Dr. med. Martin Rosewich、Johann Wolfgang Goethe University Hospital
Lung Clearance Index (LCI) and Bronchial Inflammation in Patients With Bronchiolitis Obliterans (BO)
The investigators here compare lung function parameters (RV, RV/TLC and FEF75) with the results of the Lung Clearance index (LCI) .
Further this study evaluates bronchial inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 28 years compared with an age- and sex-matched control group.
The investigators will perform a pulmonary function test (body plethysmography with DLCO) and compare the results with the LCI.
Further we will measure the fraction of exhaled nitric oxide (FeNO) and draw a blood sample to determine the level of systemic inflammation.
Finally induced sputum is collected and a cell count is performed, and cells and supernatants are analyzed for inflammatory markers.
This study will set baseline markers for future interventional studies.
研究概览
详细说明
The purpose of this study is to compare lung function values with the Lung clearance index of 20 Patients with Bronchiolitis obliterans aged between 6 up to 28 years. Further we aim to compare the bronchial Inflammation between the patients and a reference group with similar age conditions to determine possible outcome-parameters for following interventional studies.
The sputum samples will be processed and quantitatively analyzed to get a profile of the cytological composition.
(Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (PCR) (qRT-PCR) and by cytometric bead assay (CBA).)
Methods and Work Programme:
- Measurement of nitric oxide in expired air (FeNO)
- Lung function testing with spirometry and body plethysmography
- Lung clearance index (LCI)
- Bronchodilation
- Blood test: blood count, CRP, RAST, serum inflammatory mediators, (genetic markers of the non-specific pulmonary defense system)
- Induced sputum for inflammatory mediators and microbiological investigations
研究类型
观察性的
注册 (实际的)
37
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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Hessen
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Frankfurt am Main、Hessen、德国、60590
- Children's Hospital, Goethe-University
-
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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
6年 至 28年 (孩子、成人)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients suffering from Bronchiolitis obliterans and controls
描述
Inclusion Criteria:
- informed consent
- between 6 and 28 years of age
Known Bronchiolitis obliterans
- no Bronchiolitis obliterans(depending on the study group)
- Ability to perform lung function tests and inhalation
Exclusion Criteria:
- Acute illness with systemic or bronchial inflammation
- every chronic condition or infection (eg HIV, tuberculosis, malignancy)
- pregnancy
- known alcohol and/ or drug abuse
- Inability to understand the extent and scope of the study
- Participation in another study
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
学科组
患医生诊断为闭塞性细支气管炎的患者
|
|
|
控制组
年龄和性别与受试者组相匹配
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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 |
|---|---|---|
|
LCI compared to RV/TLC%-pred.
大体时间：during Visit 1 (single day, single observation)
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Correlation of these lung function Parameters in patients with BO compared to healthy controls
|
during Visit 1 (single day, single observation)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
change of sputum cell count over time (percentage of neutrophils)
大体时间：during Visit 1 (single day, single observation)
|
induced sputum will be analyzed for different cellular components such as alveolar macrophages, neutrophils, lymphocytes and others.
Epithelial cells will be excluded
|
during Visit 1 (single day, single observation)
|
|
Comparison of low CrP
大体时间：during Visit 1 (single day, single observation)
|
serum parameter for systemic inflammation
|
during Visit 1 (single day, single observation)
|
|
FVC (%-pred.)
大体时间：during Visit 1 (single day, single observation)
|
To compare FVC (%-pred.)of
patients suffering from BO with FVC (%-pred.)of a healthy control group
|
during Visit 1 (single day, single observation)
|
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FEV1 (%-pred.)
大体时间：during Visit 1 (single day, single observation)
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To compare FEV1 (%-pred.)of
patients suffering from BO withFEV1 (%-pred.)of a healthy control group
|
during Visit 1 (single day, single observation)
|
|
Tiffeneau-Index
大体时间：during Visit 1 (single day, single observation)
|
To compare Tiffeneau-Index of patients suffering from BO with Tiffeneau-Index of a healthy control group
|
during Visit 1 (single day, single observation)
|
|
sRtot (%-pred.)
大体时间：during Visit 1 (single day, single observation)
|
To compare sRtot (%-pred.) of patients suffering from BO with sRtot (%-pred.) of a healthy control group
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during Visit 1 (single day, single observation)
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RV/TLC (%-pred.)
大体时间：during Visit 1 (single day, single observation)
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To compare RV/TLC (%-pred.) of patients suffering from BO with RV/TLC (%-pred.) of a healthy control group
|
during Visit 1 (single day, single observation)
|
|
IL-6 (pg/ml)
大体时间：during Visit 1 (single day, single observation)
|
comparing IL-6 in Serum of patients with BO with healthy controls
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during Visit 1 (single day, single observation)
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IL-8 (pg/ml)
大体时间：during Visit 1 (single day, single observation)1
|
comparing IL-8 in Serum of patients with BO with healthy controls
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during Visit 1 (single day, single observation)1
|
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IL-17 (pg/ml)
大体时间：during Visit 1 (single day, single observation)
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comparing IL-17 in Serum of patients with BO with healthy controls
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during Visit 1 (single day, single observation)
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IL-6 (mRNA delta-delta-ct)
大体时间：during Visit 1 (single day, single observation)
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compare IL-6 mRNA in Sputum cells of patients with BO with healthy controls
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during Visit 1 (single day, single observation)
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IL-8 (mRNA delta-delta-ct)
大体时间：during Visit 1
|
compare IL-8 mRNA in Sputum cells of patients with BO with healthy controls
|
during Visit 1
|
|
IL-17 (mRNA delta-delta-ct)
大体时间：during Visit 1 (single day, single observation)
|
compare IL-17 mRNA in Sputum cells of patients with BO with healthy controls
|
during Visit 1 (single day, single observation)
|
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Percentage of FOXP3 positive cells in Sputum
大体时间：during Visit 1 (single day, single observation)
|
compare percentage of FOXP3 positive cells in Sputum cells of patients with BO with healthy controls
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during Visit 1 (single day, single observation)
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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。
调查人员
- 首席研究员：Martin Rosewich, MD、Johann Wolfgang Goethe University Hospital
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
- Kurland G, Michelson P. Bronchiolitis obliterans in children. Pediatr Pulmonol. 2005 Mar;39(3):193-208. Review
- Smith KJ, Fan LL. Insights into post-infectious bronchiolitis obliterans in children. Thorax. 2006 Jun;61(6):462-3.
- Pichler M, Herrmann G, Schmidt H, Ahrens P, Zielen S. Persistent adenoviral infection and chronic obstructive bronchitis in children: is there a link? Pediatr Pulmonol. 2001 Nov;32(5):367-71.
- Pichler MN, Reichenbach J, Schmidt H, Herrmann G, Zielen S. Severe adenovirus bronchiolitis in children. Acta Paediatr. 2000 Nov;89(11):1387-9.
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
2013年4月1日
初级完成 (实际的)
2013年11月1日
研究完成 (实际的)
2014年12月1日
研究注册日期
首次提交
2015年7月6日
首先提交符合 QC 标准的
2015年7月8日
首次发布 (估计)
2015年7月13日
研究记录更新
最后更新发布 (估计)
2015年7月23日
上次提交的符合 QC 标准的更新
2015年7月22日
最后验证
2015年7月1日
更多信息
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