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LCI and Bronchial Inflammation in Patients With BO (FRABO-02)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02495597
First Posted: July 13, 2015
Last Update Posted: July 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. med. Martin Rosewich, Johann Wolfgang Goethe University Hospitals
  Purpose
The investigators here compare lung function parameters (RV, RV/TLC and FEF75) with the results of the Lung Clearance index (LCI) . Further this study evaluates bronchial inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 28 years compared with an age- and sex-matched control group. The investigators will perform a pulmonary function test (body plethysmography with DLCO) and compare the results with the LCI. Further we will measure the fraction of exhaled nitric oxide (FeNO) and draw a blood sample to determine the level of systemic inflammation. Finally induced sputum is collected and a cell count is performed, and cells and supernatants are analyzed for inflammatory markers. This study will set baseline markers for future interventional studies.

Condition Intervention
Bronchiolitis Obliterans Other: no intervention - just observational

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Lung Clearance Index (LCI) and Bronchial Inflammation in Patients With Bronchiolitis Obliterans (BO)

Resource links provided by NLM:


Further study details as provided by Dr. med. Martin Rosewich, Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • LCI compared to RV/TLC%-pred. [ Time Frame: during Visit 1 (single day, single observation) ]
    Correlation of these lung function Parameters in patients with BO compared to healthy controls


Secondary Outcome Measures:
  • change of sputum cell count over time (percentage of neutrophils) [ Time Frame: during Visit 1 (single day, single observation) ]
    induced sputum will be analyzed for different cellular components such as alveolar macrophages, neutrophils, lymphocytes and others. Epithelial cells will be excluded

  • Comparison of low CrP [ Time Frame: during Visit 1 (single day, single observation) ]
    serum parameter for systemic inflammation

  • FVC (%-pred.) [ Time Frame: during Visit 1 (single day, single observation) ]
    To compare FVC (%-pred.)of patients suffering from BO with FVC (%-pred.)of a healthy control group

  • FEV1 (%-pred.) [ Time Frame: during Visit 1 (single day, single observation) ]
    To compare FEV1 (%-pred.)of patients suffering from BO withFEV1 (%-pred.)of a healthy control group

  • Tiffeneau-Index [ Time Frame: during Visit 1 (single day, single observation) ]
    To compare Tiffeneau-Index of patients suffering from BO with Tiffeneau-Index of a healthy control group

  • sRtot (%-pred.) [ Time Frame: during Visit 1 (single day, single observation) ]
    To compare sRtot (%-pred.) of patients suffering from BO with sRtot (%-pred.) of a healthy control group

  • RV/TLC (%-pred.) [ Time Frame: during Visit 1 (single day, single observation) ]
    To compare RV/TLC (%-pred.) of patients suffering from BO with RV/TLC (%-pred.) of a healthy control group

  • IL-6 (pg/ml) [ Time Frame: during Visit 1 (single day, single observation) ]
    comparing IL-6 in Serum of patients with BO with healthy controls

  • IL-8 (pg/ml) [ Time Frame: during Visit 1 (single day, single observation)1 ]
    comparing IL-8 in Serum of patients with BO with healthy controls

  • IL-17 (pg/ml) [ Time Frame: during Visit 1 (single day, single observation) ]
    comparing IL-17 in Serum of patients with BO with healthy controls

  • IL-6 (mRNA delta-delta-ct) [ Time Frame: during Visit 1 (single day, single observation) ]
    compare IL-6 mRNA in Sputum cells of patients with BO with healthy controls

  • IL-8 (mRNA delta-delta-ct) [ Time Frame: during Visit 1 ]
    compare IL-8 mRNA in Sputum cells of patients with BO with healthy controls

  • IL-17 (mRNA delta-delta-ct) [ Time Frame: during Visit 1 (single day, single observation) ]
    compare IL-17 mRNA in Sputum cells of patients with BO with healthy controls

  • Percentage of FOXP3 positive cells in Sputum [ Time Frame: during Visit 1 (single day, single observation) ]
    compare percentage of FOXP3 positive cells in Sputum cells of patients with BO with healthy controls


Biospecimen Retention:   Samples With DNA
blood, sputum cells, sputum supernatans

Enrollment: 37
Study Start Date: April 2013
Study Completion Date: December 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subject-Group
Patients suffering from doctors diagnosed bronchiolitis obliterans
Other: no intervention - just observational
Control Group
age- and sex matched to subject-group
Other: no intervention - just observational

Detailed Description:

The purpose of this study is to compare lung function values with the Lung clearance index of 20 Patients with Bronchiolitis obliterans aged between 6 up to 28 years. Further we aim to compare the bronchial Inflammation between the patients and a reference group with similar age conditions to determine possible outcome-parameters for following interventional studies.

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 (PCR) (qRT-PCR) and by cytometric bead assay (CBA).)

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)
  • Induced sputum for inflammatory mediators and microbiological investigations
  Eligibility

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Ages Eligible for Study:   6 Years to 28 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering from Bronchiolitis obliterans and controls
Criteria

Inclusion Criteria:

  • informed consent
  • between 6 and 28 years of age
  • Known Bronchiolitis obliterans

    • no Bronchiolitis obliterans(depending on the study group)
  • Ability to perform lung function tests and inhalation

Exclusion Criteria:

  • Acute illness with systemic or bronchial inflammation
  • every chronic condition or infection (eg HIV, tuberculosis, malignancy)
  • pregnancy
  • known alcohol and/ or drug abuse
  • Inability to understand the extent and scope of the study
  • Participation in another study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02495597


Locations
Germany
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
  More Information

Additional Information:
Responsible Party: Dr. med. Martin Rosewich, Principal Investigator, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT02495597     History of Changes
Other Study ID Numbers: EC 124/13
First Submitted: July 6, 2015
First Posted: July 13, 2015
Last Update Posted: July 23, 2015
Last Verified: July 2015

Keywords provided by Dr. med. Martin Rosewich, Johann Wolfgang Goethe University Hospitals:
bronchial inflammation
Bronchiolitis obliterans
Sputum
Blood
Inflammation
adaptive immune system
innate immune system

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