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

April 3, 2013 updated by: Dr. med. Martin Rosewich, Johann Wolfgang Goethe University Hospital

Lung Function and Bronchial Inflammation in Patients With Bronchiolithis Obliterans

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.

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
        • Children's Hospital, Goethe-University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients suffering from Bronchiolitis obliterans and controls

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Subject-Group
Patients suffering from doctors diagnosed bronchiolitis obliterans
Control Group
age- and sex matched to subject-group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of FEF75 over time
Time Frame: V1: Day 1 - V2: Day 28-42
Look for changes/ variability of this lung function parameter
V1: Day 1 - V2: Day 28-42

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of sputum cell count over time
Time Frame: V1: Day 1 - V2: Day 28-42
induced sputum will be analyzed for different cellular components such as alveolar macrophages, neutrophils, lymphocytes and others. Epithelial cells will be excluded
V1: Day 1 - V2: Day 28-42
change of low CrP over time
Time Frame: V1: Day 1 - V2: Day 28-42
serum parameter for systemic inflammation
V1: Day 1 - V2: Day 28-42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 26, 2012

First Submitted That Met QC Criteria

June 29, 2012

First Posted (Estimate)

July 4, 2012

Study Record Updates

Last Update Posted (Estimate)

April 4, 2013

Last Update Submitted That Met QC Criteria

April 3, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BO2012-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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