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
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: 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 August 21, 2014