Lung Function, LCI, Bronchial Inflammation and Epigenetics of Patients With BO

Bronchiolitis Obliterans Clinical Trial

— FRABO-03  

Official title:

Lungfunction, Lung Clearance Index, Bronchial Inflammation and Epigenetics of Patients With Bronchiolitis Obliterans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02627833
• Other study ID #: MRosewich
• 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. 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

• Bronchiolitis
• Bronchiolitis Obliterans
• Inflammation

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