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

Johann Wolfgang Goethe University Hospital

Status: Completed

Conditions: Bronchiolitis Obliterans

Treatments: Other: no intervention - just observational

Study type: Observational

Funder types: Other

Identifiers

NCT02495597

EC 124/13

Details and patient eligibility

About

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.

Full 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

Enrollment: 37 patients

Sex: All

Ages: 6 to 28 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

37 participants in 2 patient groups

Subject-Group

Description:

Patients suffering from doctors diagnosed bronchiolitis obliterans

Treatment:

Other: no intervention - just observational

Control Group

Description:

age- and sex matched to subject-group

Treatment:

Other: no intervention - just observational