Bronchiolitis Obliterans Clinical Trial
— FRABO-03Official title:
Lungfunction, Lung Clearance Index, Bronchial Inflammation and Epigenetics of Patients With Bronchiolitis Obliterans
NCT number | NCT02627833 |
Other study ID # | MRosewich |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | December 9, 2015 |
Last updated | December 9, 2015 |
Start date | October 2015 |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Years to 35 Years |
Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | Children's Hospital, Goethe-University | Frankfurt am Main | Hessen |
Lead Sponsor | Collaborator |
---|---|
Johann Wolfgang Goethe University Hospitals |
Germany,
Boehler A, Kesten S, Weder W, Speich R. Bronchiolitis obliterans after lung transplantation: a review. Chest. 1998 Nov;114(5):1411-26. Review. — View Citation
Kurland G, Michelson P. Bronchiolitis obliterans in children. Pediatr Pulmonol. 2005 Mar;39(3):193-208. Review. — View Citation
Moonnumakal SP, Fan LL. Bronchiolitis obliterans in children. Curr Opin Pediatr. 2008 Jun;20(3):272-8. doi: 10.1097/MOP.0b013e3282ff62e9. Review. — View Citation
Motameny S, Wolters S, Nürnberg 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. — View Citation
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. — View Citation
Rosewich M, Zissler UM, Kheiri T, Voss S, Eickmeier O, Schulze J, Herrmann E, Dücker 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Lung clearance index (LCI) | Determine Lung clearance index with the Oxygen washout method | single day observation | No |
Other | FVC [%-pred.] | Compare FVC [%-pred.] of BO Patients with a healthy control group | single day observation | No |
Other | FEV1 [%-pred.] | Compare FEV1[%-pred.] of BO Patients with a healthy control group | single day observation | No |
Other | Tiffeneau Index | Compare Tiffeneau-Index of BO Patients with a healthy control group | single day observation | No |
Other | sRtot [%-pred.] | Compare sRtot[%-pred.] of BO Patients with a healthy control group | single day observation | No |
Other | RV/TLC [%-pred.] | Compare RV/TLC[%-pred.] of BO Patients with a healthy control group | single day observation | No |
Other | DLCO [%-pred.] | Compare difffusion capacity of the lung for CO [%-pred.] of BO Patients with a healthy control group | single day observation | No |
Other | IL-6 (pg/ml) | Comparing IL-6 in Serum of patients with BO with a healthy control group | single day observation | No |
Other | IL-8 (pg/ml | Comparing IL-8 in Serum of patients with BO with a healthy control group | single day observation | No |
Other | Il-17 (pg/ml) | Comparing IL-17 in Serum of patients with BO with a healthy control group | single day observation | No |
Other | CrP (mg/dl) | Comparing CrP in Serum of patients with BO with a healthy control group | single day observation | No |
Other | FeNO ppb | Comparing FeNO in exhaled air of patients with BO with a healthy control group | single day observation | No |
Other | Sputum cell count | Comparing sputum cell counts of patients with BO with a healthy control group | single day observation | No |
Primary | miRNA Status | Blood sample to determine candidate miRNA for Bronchiolitis obliterans | single day observation | No |
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