NCT02495597

LCI and Bronchial Inflammation in Patients With BO

Lung Clearance Index (LCI) and Bronchial Inflammation in Patients With Bronchiolitis Obliterans (BO)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 37 (actual)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 28 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Bronchiolitis Obliterans

Interventions

Type	Name	Description
OTHER	no intervention - just observational

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-11-01
• Completion: 2014-12-01
• First posted: 2015-07-13
• Last updated: 2015-07-23

Locations

1 site across 1 country: Germany