Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-03 @ 2:07 PM
Study NCT ID:
NCT02627833
Status:
UNKNOWN
Last Update Posted:
2015-12-11
First Post:
2015-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Function, LCI, Bronchial Inflammation and Epigenetics of Patients With BO
Sponsor:
Johann Wolfgang Goethe University Hospital
Organization:
Study Overview
Official Title:
Lungfunction, Lung Clearance Index, Bronchial Inflammation and Epigenetics of Patients With Bronchiolitis Obliterans
Status:
UNKNOWN
Status Verified Date:
2015-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FRABO-03
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: