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

• Conditions: Bronchiolitis Obliterans

• Registration Number: NCT02627833
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

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

Study Timeline

• Study Start: 2015-10
• Status Verified: 2015-12
• Study First Submitted: 2015-12-09
• Study First Submitted QC: 2015-12-09
• Last Update Submitted: 2015-12-09
• Study First Posted: 2015-12-11
• Last Update Posted: 2015-12-11
• Primary Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
miRNA Status	single day observation	Blood sample to determine candidate miRNA for Bronchiolitis obliterans

Trial Locations

Locations (1)

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