Lung Function, LCI, Bronchial Inflammation and Epigenetics of Patients With BO
NCT ID: NCT02627833
Last Updated: 2015-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2015-10-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Subject Group
Patients suffering from Bronchiolitis Obliterans
observation
Record lung function, Lung clearance index, inflammatory status
Control Group
Age and sex matched control group
observation
Record lung function, Lung clearance index, inflammatory status
Interventions
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observation
Record lung function, Lung clearance index, inflammatory status
Eligibility Criteria
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Inclusion Criteria
* 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
* \>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
6 Years
35 Years
ALL
Yes
Sponsors
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Johann Wolfgang Goethe University Hospital
OTHER
Responsible Party
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Dr. med. Martin Rosewich
Principal Investigator
Principal Investigators
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Martin Rosewich, MD
Role: PRINCIPAL_INVESTIGATOR
Johann Wolfgang Goethe University Hospital
Locations
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Children's Hospital, Goethe-University
Frankfurt am Main, Hesse, Germany
Countries
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Central Contacts
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Facility Contacts
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Martin Rosewich, MD
Role: primary
Stefan Zielen, MD, PhD
Role: backup
References
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Kurland G, Michelson P. Bronchiolitis obliterans in children. Pediatr Pulmonol. 2005 Mar;39(3):193-208. doi: 10.1002/ppul.20145.
Boehler A, Kesten S, Weder W, Speich R. Bronchiolitis obliterans after lung transplantation: a review. Chest. 1998 Nov;114(5):1411-26. doi: 10.1378/chest.114.5.1411. No abstract available.
Moonnumakal SP, Fan LL. Bronchiolitis obliterans in children. Curr Opin Pediatr. 2008 Jun;20(3):272-8. doi: 10.1097/MOP.0b013e3282ff62e9.
Pichler M, Herrmann G, Schmidt H, Ahrens P, Zielen S. Persistent adenoviral infection and chronic obstructive bronchitis in children: is there a link? Pediatr Pulmonol. 2001 Nov;32(5):367-71. doi: 10.1002/ppul.1145.
Rosewich M, Zissler UM, Kheiri T, Voss S, Eickmeier O, Schulze J, Herrmann E, Ducker RP, Schubert R, Zielen S. Airway inflammation in children and adolescents with bronchiolitis obliterans. Cytokine. 2015 May;73(1):156-62. doi: 10.1016/j.cyto.2014.10.026. Epub 2015 Mar 6.
Motameny S, Wolters S, Nurnberg P, Schumacher B. Next Generation Sequencing of miRNAs - Strategies, Resources and Methods. Genes (Basel). 2010 Jun 3;1(1):70-84. doi: 10.3390/genes1010070.
Other Identifiers
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MRosewich
Identifier Type: -
Identifier Source: org_study_id