FRABO-03: Lung Function, LCI, Bronchial Inflammation and Epigenetics of Patients With BO

• Sponsor: Johann Wolfgang Goethe University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02627833
• Collaborator: (none)
• Enrollment: 20
• Location: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis Obliterans	Other: observation

Detailed 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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Lungfunction, Lung Clearance Index, Bronchial Inflammation and Epigenetics of Patients With Bronchiolitis Obliterans
• Study Start Date: Oct 1, 2015
• Anticipated Primary Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Subject Group Patients suffering from Bronchiolitis Obliterans	Other: observation; Record lung function, Lung clearance index, inflammatory status
Control Group Age and sex matched control group	Other: observation; Record lung function, Lung clearance index, inflammatory status

Outcome Measures

Primary Outcome Measures

1. miRNA Status [single day observation]

   Blood sample to determine candidate miRNA for Bronchiolitis obliterans

Other Outcome Measures

1. Lung clearance index (LCI) [single day observation]

   Determine Lung clearance index with the Oxygen washout method

2. FVC [%-pred.] [single day observation]

   Compare FVC [%-pred.] of BO Patients with a healthy control group

3. FEV1 [%-pred.] [single day observation]

   Compare FEV1[%-pred.] of BO Patients with a healthy control group

4. Tiffeneau Index [single day observation]

   Compare Tiffeneau-Index of BO Patients with a healthy control group

5. sRtot [%-pred.] [single day observation]

   Compare sRtot[%-pred.] of BO Patients with a healthy control group

6. RV/TLC [%-pred.] [single day observation]

   Compare RV/TLC[%-pred.] of BO Patients with a healthy control group

7. DLCO [%-pred.] [single day observation]

   Compare difffusion capacity of the lung for CO [%-pred.] of BO Patients with a healthy control group

8. IL-6 (pg/ml) [single day observation]

   Comparing IL-6 in Serum of patients with BO with a healthy control group

9. IL-8 (pg/ml [single day observation]

   Comparing IL-8 in Serum of patients with BO with a healthy control group

10. Il-17 (pg/ml) [single day observation]

    Comparing IL-17 in Serum of patients with BO with a healthy control group

11. CrP (mg/dl) [single day observation]

    Comparing CrP in Serum of patients with BO with a healthy control group

12. FeNO ppb [single day observation]

    Comparing FeNO in exhaled air of patients with BO with a healthy control group

13. Sputum cell count [single day observation]

    Comparing sputum cell counts of patients with BO with a healthy control group

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital, Goethe-University	Frankfurt am Main	Hessen	Germany	60590

Sponsors and Collaborators

• Johann Wolfgang Goethe University Hospital

Investigators

• Principal Investigator: Martin Rosewich, MD, Johann Wolfgang Goethe University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• Boehler A, Kesten S, Weder W, Speich R. Bronchiolitis obliterans after lung transplantation: a review. Chest. 1998 Nov;114(5):1411-26. Review.
• Kurland G, Michelson P. Bronchiolitis obliterans in children. Pediatr Pulmonol. 2005 Mar;39(3):193-208. Review.
• Moonnumakal SP, Fan LL. Bronchiolitis obliterans in children. Curr Opin Pediatr. 2008 Jun;20(3):272-8. doi: 10.1097/MOP.0b013e3282ff62e9. Review.

• Responsible Party: Dr. med. Martin Rosewich, Principal Investigator, Johann Wolfgang Goethe University Hospital
• ClinicalTrials.gov Identifier: NCT02627833
• Other Study ID Numbers: MRosewich
• First Posted: Dec 11, 2015
• Last Update Posted: Dec 11, 2015
• Last Verified: Dec 1, 2015

• Keywords provided by Dr. med. Martin Rosewich, Principal Investigator, Johann Wolfgang Goethe University Hospital: induced Sputum; lung clearance index; miRNA; inflammation; chronic lung disease
• Additional relevant MeSH terms: Bronchiolitis; Bronchiolitis Obliterans; Inflammation

Study Results

No Results Posted as of Dec 11, 2015