LCI and Bronchial Inflammation in Patients With BO

Completed

• Conditions: Bronchiolitis Obliterans
• Interventions: Other: no intervention - just observational

• Registration Number: NCT02495597
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief 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

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2013-11
• Study Completion: 2014-12
• Status Verified: 2015-07
• Study First Submitted: 2015-07-06
• Study First Submitted QC: 2015-07-08
• Study First Posted: 2015-07-13
• Last Update Submitted: 2015-07-22
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subject-Group	no intervention - just observational	Patients suffering from doctors diagnosed bronchiolitis obliterans
Control Group	no intervention - just observational	age- and sex matched to subject-group

Primary Outcome Measures

Name	Time	Method
LCI compared to RV/TLC%-pred.	during Visit 1 (single day, single observation)	Correlation of these lung function Parameters in patients with BO compared to healthy controls

Secondary Outcome Measures

Name	Time	Method
Comparison of low CrP	during Visit 1 (single day, single observation)	serum parameter for systemic inflammation
RV/TLC (%-pred.)	during Visit 1 (single day, single observation)	To compare RV/TLC (%-pred.) of patients suffering from BO with RV/TLC (%-pred.) of a healthy control group
FEV1 (%-pred.)	during Visit 1 (single day, single observation)	To compare FEV1 (%-pred.)of patients suffering from BO withFEV1 (%-pred.)of a healthy control group
IL-17 (mRNA delta-delta-ct)	during Visit 1 (single day, single observation)	compare IL-17 mRNA in Sputum cells of patients with BO with healthy controls
FVC (%-pred.)	during Visit 1 (single day, single observation)	To compare FVC (%-pred.)of patients suffering from BO with FVC (%-pred.)of a healthy control group
Tiffeneau-Index	during Visit 1 (single day, single observation)	To compare Tiffeneau-Index of patients suffering from BO with Tiffeneau-Index of a healthy control group
IL-8 (pg/ml)	during Visit 1 (single day, single observation)1	comparing IL-8 in Serum of patients with BO with healthy controls
IL-6 (mRNA delta-delta-ct)	during Visit 1 (single day, single observation)	compare IL-6 mRNA in Sputum cells of patients with BO with healthy controls
Percentage of FOXP3 positive cells in Sputum	during Visit 1 (single day, single observation)	compare percentage of FOXP3 positive cells in Sputum cells of patients with BO with healthy controls
sRtot (%-pred.)	during Visit 1 (single day, single observation)	To compare sRtot (%-pred.) of patients suffering from BO with sRtot (%-pred.) of a healthy control group
IL-6 (pg/ml)	during Visit 1 (single day, single observation)	comparing IL-6 in Serum of patients with BO with healthy controls
change of sputum cell count over time (percentage of neutrophils)	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
IL-17 (pg/ml)	during Visit 1 (single day, single observation)	comparing IL-17 in Serum of patients with BO with healthy controls
IL-8 (mRNA delta-delta-ct)	during Visit 1	compare IL-8 mRNA in Sputum cells of patients with BO with healthy controls

Trial Locations

Locations (1)

Children's Hospital, Goethe-University; 🇩🇪 Frankfurt am Main, Hessen, Germany