Bronchial Inflammation in Patients With Bronchiolithis Obliterans (FRABO-02)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. med. Martin Rosewich, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01633385
First received: June 26, 2012
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

The investigators plan to study the variability of lung function parameters and bronchial inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 25 years compared with an age- and sex-matched control group. The investigators will perform a pulmonary function test (body plethysmography with TLCO), and measure the fraction of exhaled nitric oxide (eNO). Further a blood sample is drawn to determine the systemic inflammation. Finally induced sputum is collected and a cell count is performed, and cells and supernatants are analyzed for inflammatory markers. This investigation will be repeated after 4-6 weeks. The aim of this study is to define baseline values and the variability of possible outcome parameters for future interventional studies.


Condition
Bronchiolitis Obliterans

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Lung Function and Bronchial Inflammation in Patients With Bronchiolithis Obliterans

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change of FEF75 over time [ Time Frame: V1: Day 1 - V2: Day 28-42 ] [ Designated as safety issue: No ]
    Look for changes/ variability of this lung function parameter


Secondary Outcome Measures:
  • change of sputum cell count over time [ Time Frame: V1: Day 1 - V2: Day 28-42 ] [ Designated as safety issue: No ]
    induced sputum will be analyzed for different cellular components such as alveolar macrophages, neutrophils, lymphocytes and others. Epithelial cells will be excluded

  • change of low CrP over time [ Time Frame: V1: Day 1 - V2: Day 28-42 ] [ Designated as safety issue: No ]
    serum parameter for systemic inflammation


Biospecimen Retention:   Samples With DNA

blood, sputum cells, sputum supernatans


Enrollment: 37
Study Start Date: April 2012
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Subject-Group
Patients suffering from doctors diagnosed bronchiolitis obliterans
Control Group
age- and sex matched to subject-group

Detailed Description:

The purpose of this study is to characterize the variability of lung function values and bronchial inflammation of 20 Patients with Bronchiolitis obliterans aged between 6 up to 25 years. The patients' data will be compared with the results of 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:

This study consists of two study visits (V1 and V2)

V1:

  • Measurement of nitric oxide in expired air (eNO)
  • Lung function testing with spirometry and body plethysmography
  • Bronchodilation
  • Lung function testing with spirometry and body plethysmography
  • 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

V2:

  • Measurement of nitric oxide in expired air (eNO)
  • Lung function testing with spirometry and body plethysmography
  • Bronchodilation
  • Lung function testing with spirometry and body plethysmography
  • Induced sputum for inflammatory mediators and microbiological investigations
  Eligibility

Ages Eligible for Study:   6 Years to 25 Years
Genders Eligible for Study:   Both
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 25 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633385

Locations
Germany
Children's Hospital, Goethe-University
Frankfurt am Main, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. med. Martin Rosewich, Principal Investigator, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01633385     History of Changes
Other Study ID Numbers: BO2012-02
Study First Received: June 26, 2012
Last Updated: April 3, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
bronchial inflammation
Bronchiolitis obliterans
Sputum
Blood
Inflammation
adaptive immune system
innate immune system

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

ClinicalTrials.gov processed this record on April 16, 2014