Bronchial Inflammation in Patients With Bronchiolithis Obliterans

Completed

• Conditions: Bronchiolitis Obliterans

• Registration Number: NCT01633385
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2012-04
• Primary Completion: 2012-06
• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-06-29
• Study First Posted: 2012-07-04
• Study Completion: 2012-12
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-03
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of FEF75 over time	V1: Day 1 - V2: Day 28-42	Look for changes/ variability of this lung function parameter

Secondary Outcome Measures

Name	Time	Method
change of sputum cell count over time	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
change of low CrP over time	V1: Day 1 - V2: Day 28-42	serum parameter for systemic inflammation

Trial Locations

Locations (1)

Children's Hospital, Goethe-University; 🇩🇪 Frankfurt am Main, Hessen, Germany