Lung Clearance Index (LCI) and Bronchial Inflammation in Patients With Bronchiolitis Obliterans (BO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- LCI compared to RV/TLC%-pred.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 28 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
LCI compared to RV/TLC%-pred.
时间窗: during Visit 1 (single day, single observation)
Correlation of these lung function Parameters in patients with BO compared to healthy controls
次要结局
- Comparison of low CrP(during Visit 1 (single day, single observation))
- RV/TLC (%-pred.)(during Visit 1 (single day, single observation))
- FEV1 (%-pred.)(during Visit 1 (single day, single observation))
- IL-17 (mRNA delta-delta-ct)(during Visit 1 (single day, single observation))
- FVC (%-pred.)(during Visit 1 (single day, single observation))
- Tiffeneau-Index(during Visit 1 (single day, single observation))
- IL-8 (pg/ml)(during Visit 1 (single day, single observation)1)
- IL-6 (mRNA delta-delta-ct)(during Visit 1 (single day, single observation))
- Percentage of FOXP3 positive cells in Sputum(during Visit 1 (single day, single observation))
- sRtot (%-pred.)(during Visit 1 (single day, single observation))
- IL-6 (pg/ml)(during Visit 1 (single day, single observation))
- change of sputum cell count over time (percentage of neutrophils)(during Visit 1 (single day, single observation))
- IL-17 (pg/ml)(during Visit 1 (single day, single observation))
- IL-8 (mRNA delta-delta-ct)(during Visit 1)
研究者
Dr. med. Martin Rosewich
Principal Investigator
Johann Wolfgang Goethe University Hospital