Lung Function, LCI, Bronchial Inflammation and Epigenetics of Patients With BO

Study Overview
=================
Brief Summary
-----------------
Bronchiolitis obliterans is a chronic disease in which a persistent inflammatory process leads to obliteration of the small airways. Pulmonary function tests (body plethysmography with DLCO, lung clearance index) are performed and the fraction of exhaled nitric oxide is measured. A blood test is following to determine the inflammatory status und collect miRNA. Induced Sputum will be obtained.

Detailed Description
-----------------
The purpose of this study is to compare miRNA pattern, lung function values, bronchial inflammation and the Lung clearance index of Patients with Bronchiolitis obliterans aged between 6 up to 30 years of age with a matched control group. 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 (qRT-PCR) and by cytometric bead assay (CBA). miRNA samples will be collected, processand compared with the miRNA database at http://www.mirbase.org/ 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), miRNA analysis Induced sputum for inflammatory mediators and microbiological investigations

Official Title
-----------------
Lungfunction, Lung Clearance Index, Bronchial Inflammation and Epigenetics of Patients With Bronchiolitis Obliterans

Conditions
-----------------
Bronchiolitis Obliterans

Intervention / Treatment
-----------------
* Other: observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent age between 6 an 35 years known bronchiolitis obliterans (Group Bronchiolitis)/ no Bronchiolitis Obliterans (Group matched controls) ability to perform lung function tests and inhale correctly Exclusion Criteria: <6 years of age >35 years of age acute systemic or bronchial inflammation other chronic diseases or infection (e.g. HIV, Tbc, malignoma) pregnancy alcohol, drug or illegal drug abuse disability to register the range and consequences of the study actual participation in another study

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subject Group<br>Patients suffering from Bronchiolitis Obliterans | Other: observation<br>* Record lung function, Lung clearance index, inflammatory status<br>|
| Control Group<br>Age and sex matched control group | Other: observation<br>* Record lung function, Lung clearance index, inflammatory status<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| miRNA Status | Blood sample to determine candidate miRNA for Bronchiolitis obliterans | single day observation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
induced Sputum, lung clearance index, miRNA, inflammation, chronic lung disease