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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date December 2015
Source Johann Wolfgang Goethe University Hospitals
Contact Martin Rosewich, MD
Phone +49-69-6301
Email Martin.rosewich@kgu.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
observation
Record lung function, Lung clearance index, inflammatory status

Locations

Country Name City State
Germany Children's Hospital, Goethe-University Frankfurt am Main Hessen

Sponsors (1)

Lead Sponsor Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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

Outcome

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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