Clinical trial NCT01633385: Bronchial Inflammation in Patients With Bronchiolithis Obliterans
Official title: Lung Function and Bronchial Inflammation in Patients With Bronchiolithis Obliterans
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: 2012-07-04
Enrollment: 37
Sex: ALL
Minimum age (years): 6
Maximum age (years): 25
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 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

Eligibility 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

Primary outcomes:
measure: Change of FEF75 over time
timeFrame: V1: Day 1 - V2: Day 28-42
Secondary outcomes:
measure: change of sputum cell count over time
timeFrame: V1: Day 1 - V2: Day 28-42
measure: change of low CrP over time
timeFrame: V1: Day 1 - V2: Day 28-42
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Children's Hospital, Goethe-University
state: Hessen
Study officials:
References: