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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Johann Wolfgang Goethe University Hospital
Sponsor:
Information provided by (Responsible Party):
Dr. med. Martin Rosewich, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT02627833
First received: December 9, 2015
Last updated: NA
Last verified: December 2015
History: No changes posted
  Purpose
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 Intervention
Bronchiolitis Obliterans
Other: observation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Lungfunction, Lung Clearance Index, Bronchial Inflammation and Epigenetics of Patients With Bronchiolitis Obliterans

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospital:

Primary Outcome Measures:
  • miRNA Status [ Time Frame: single day observation ]
    Blood sample to determine candidate miRNA for Bronchiolitis obliterans


Other Outcome Measures:
  • Lung clearance index (LCI) [ Time Frame: single day observation ]
    Determine Lung clearance index with the Oxygen washout method

  • FVC [%-pred.] [ Time Frame: single day observation ]
    Compare FVC [%-pred.] of BO Patients with a healthy control group

  • FEV1 [%-pred.] [ Time Frame: single day observation ]
    Compare FEV1[%-pred.] of BO Patients with a healthy control group

  • Tiffeneau Index [ Time Frame: single day observation ]
    Compare Tiffeneau-Index of BO Patients with a healthy control group

  • sRtot [%-pred.] [ Time Frame: single day observation ]
    Compare sRtot[%-pred.] of BO Patients with a healthy control group

  • RV/TLC [%-pred.] [ Time Frame: single day observation ]
    Compare RV/TLC[%-pred.] of BO Patients with a healthy control group

  • DLCO [%-pred.] [ Time Frame: single day observation ]
    Compare difffusion capacity of the lung for CO [%-pred.] of BO Patients with a healthy control group

  • IL-6 (pg/ml) [ Time Frame: single day observation ]
    Comparing IL-6 in Serum of patients with BO with a healthy control group

  • IL-8 (pg/ml [ Time Frame: single day observation ]
    Comparing IL-8 in Serum of patients with BO with a healthy control group

  • Il-17 (pg/ml) [ Time Frame: single day observation ]
    Comparing IL-17 in Serum of patients with BO with a healthy control group

  • CrP (mg/dl) [ Time Frame: single day observation ]
    Comparing CrP in Serum of patients with BO with a healthy control group

  • FeNO ppb [ Time Frame: single day observation ]
    Comparing FeNO in exhaled air of patients with BO with a healthy control group

  • Sputum cell count [ Time Frame: single day observation ]
    Comparing sputum cell counts of patients with BO with a healthy control group


Biospecimen Retention:   Samples With DNA
Cells of induced Sputum, blood sample

Estimated Enrollment: 20
Study Start Date: October 2015
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   6 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with the assured diagnose of Bronchiolitis Obliterans and controls without this disease.
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02627833

Contacts
Contact: Martin Rosewich, MD +49-69-6301 ext 5381 Martin.rosewich@kgu.de

Locations
Germany
Children's Hospital, Goethe-University Recruiting
Frankfurt am Main, Hessen, Germany, 60590
Contact: Martin Rosewich, MD    49-69-6301 ext 5381    Martin.Rosewich@kgu.de   
Contact: Stefan Zielen, MD, PhD    49-69-6301 ext 83063    Stefan.Zielen@kgu.de   
Principal Investigator: Martin Rosewich, MD         
Sub-Investigator: Stefan Zielen, MD, PhD         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
Principal Investigator: Martin Rosewich, MD Johann Wolfgang Goethe University Hospital
  More Information

Publications:
Responsible Party: Dr. med. Martin Rosewich, Principal Investigator, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT02627833     History of Changes
Other Study ID Numbers: MRosewich
Study First Received: December 9, 2015
Last Updated: December 9, 2015

Keywords provided by Johann Wolfgang Goethe University Hospital:
induced Sputum
lung clearance index
miRNA
inflammation
chronic lung disease

Additional relevant MeSH terms:
Inflammation
Bronchiolitis
Bronchiolitis Obliterans
Pathologic Processes
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on March 29, 2017