Clinical Status and Bronchial Inflammation in Patients With Bronchiolitis Obliterans (Frabo)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01327248|
Recruitment Status : Completed
First Posted : April 1, 2011
Last Update Posted : June 27, 2012
The aim of this case-control study is the characterization of the bronchial and systemic inflammation of children and young adults with bronchiolitis obliterans.
On the first visit subjects are asked to perform a lung function test (spirometry, body plethysmography with helium). Further levels of eNO and eCO are determined. A blood sample is drawn to describe the inflammatory status. Bronchial inflammation will be measured in induced sputum. At the second visit, a non-specific bronchial provocation testing (PD20 FEV1 methacholine) is performed.
|Condition or disease|
The aim of this study is the characterization of patients with bronchiolitis obliterans in terms of lung function, bronchial hyperreactivity and the degree of the systemic and bronchial inflammation.
Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (PCR) (qRT-PCR) and by cytometric bead assay (CBA). Components of the innate immune system (mannose-binding protein, TLR recognition proteins and surfactant proteins) are genetically determined from sputum or blood respectively. In the conduct of this study the investigators will retrospectively and systematically evaluate the available high-resolution computed tomography (HRCT) studies of affected patients
Methods and Work Programme:
This study consists of two study visits (V1 and V2)
- Measurement of nitric oxide in expired air (eNO)
- Measurement of carbon monoxide in the exhaled air (eCO)
- Lung function testing with spirometry and body plethysmography
- 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
• Unspecific bronchial provocation test with methacholine (PD20 FEV1 methacholine)
Children and young people (6 - 25 years of age). Both the patients and the healthy subjects are recruited from the outpatient clinic of Pediatric Allergy and Pulmonology.
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Observational Model:||Case Control|
|Official Title:||Clinical Status and Bronchial Inflammation in Patients With Bronchiolitis Obliterans|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||June 2012|
20 Patients suffering from bronchiolitis obliterans
20 matched controls not suffering from bronchiolitis obliterans
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01327248
|Children's Hospital, Goethe-University|
|Frankfurt am Main, Hessen, Germany, 60590|
|Principal Investigator:||Martin Rosewich, MD||Goethe University|