Clinical trial NCT02495597: LCI and Bronchial Inflammation in Patients With BO
Official title: Lung Clearance Index (LCI) and Bronchial Inflammation in Patients With Bronchiolitis Obliterans (BO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchiolitis Obliterans
Keywords: bronchial inflammation
Bronchiolitis obliterans
Sputum
Blood
Inflammation
adaptive immune system
innate immune system
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2015-07-13
Enrollment: 37
Sex: ALL
Minimum age (years): 6
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from Bronchiolitis obliterans and controls

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: LCI compared to RV/TLC%-pred.
timeFrame: during Visit 1 (single day, single observation)
Secondary outcomes:
measure: change of sputum cell count over time (percentage of neutrophils)
timeFrame: during Visit 1 (single day, single observation)
measure: Comparison of low CrP
timeFrame: during Visit 1 (single day, single observation)
measure: FVC (%-pred.)
timeFrame: during Visit 1 (single day, single observation)
measure: FEV1 (%-pred.)
timeFrame: during Visit 1 (single day, single observation)
measure: Tiffeneau-Index
timeFrame: during Visit 1 (single day, single observation)
measure: sRtot (%-pred.)
timeFrame: during Visit 1 (single day, single observation)
measure: RV/TLC (%-pred.)
timeFrame: during Visit 1 (single day, single observation)
measure: IL-6 (pg/ml)
timeFrame: during Visit 1 (single day, single observation)
measure: IL-8 (pg/ml)
timeFrame: during Visit 1 (single day, single observation)1
measure: IL-17 (pg/ml)
timeFrame: during Visit 1 (single day, single observation)
measure: IL-6 (mRNA delta-delta-ct)
timeFrame: during Visit 1 (single day, single observation)
measure: IL-8 (mRNA delta-delta-ct)
timeFrame: during Visit 1
measure: IL-17 (mRNA delta-delta-ct)
timeFrame: during Visit 1 (single day, single observation)
measure: Percentage of FOXP3 positive cells in Sputum
timeFrame: during Visit 1 (single day, single observation)
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Children's Hospital, Goethe-University
state: Hessen
Study officials:
affiliation: Johann Wolfgang Goethe University Hospital
name: Martin Rosewich, MD
role: PRINCIPAL_INVESTIGATOR
References: