Skip to content

Lung Function, LCI, Bronchial Inflammation and Epigenetics of Patients With BO

Lungfunction, Lung Clearance Index, Bronchial Inflammation and Epigenetics of Patients With Bronchiolitis Obliterans

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02627833
Acronym
FRABO-03
Enrollment
20
Registered
2015-12-11
Start date
2015-10-31
Completion date
Unknown
Last updated
2015-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis Obliterans

Keywords

induced Sputum, lung clearance index, miRNA, inflammation, chronic lung disease

Brief summary

Bronchiolitis obliterans is a chronic disease in which a persistent inflammatory process leads to obliteration of the small airways. Pulmonary function tests (body plethysmography with DLCO, lung clearance index) are performed and the fraction of exhaled nitric oxide is measured. A blood test is following to determine the inflammatory status und collect miRNA. Induced Sputum will be obtained.

Detailed description

The purpose of this study is to compare miRNA pattern, lung function values, bronchial inflammation and the Lung clearance index of Patients with Bronchiolitis obliterans aged between 6 up to 30 years of age with a matched control group. 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 (qRT-PCR) and by cytometric bead assay (CBA). miRNA samples will be collected, processand compared with the miRNA database at http://www.mirbase.org/ 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), miRNA analysis * Induced sputum for inflammatory mediators and microbiological investigations

Interventions

OTHERobservation

Record lung function, Lung clearance index, inflammatory status

Sponsors

Johann Wolfgang Goethe University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* informed consent * age between 6 an 35 years * known bronchiolitis obliterans (Group Bronchiolitis)/ no Bronchiolitis Obliterans (Group matched controls) * ability to perform lung function tests and inhale correctly

Exclusion criteria

* \<6 years of age * \>35 years of age * acute systemic or bronchial inflammation * other chronic diseases or infection (e.g. HIV, Tbc, malignoma) * pregnancy * alcohol, drug or illegal drug abuse * disability to register the range and consequences of the study * actual participation in another study

Design outcomes

Primary

MeasureTime frameDescription
miRNA Statussingle day observationBlood sample to determine candidate miRNA for Bronchiolitis obliterans

Other

MeasureTime frameDescription
FVC [%-pred.]single day observationCompare FVC \[%-pred.\] of BO Patients with a healthy control group
FEV1 [%-pred.]single day observationCompare FEV1\[%-pred.\] of BO Patients with a healthy control group
Tiffeneau Indexsingle day observationCompare Tiffeneau-Index of BO Patients with a healthy control group
sRtot [%-pred.]single day observationCompare sRtot\[%-pred.\] of BO Patients with a healthy control group
RV/TLC [%-pred.]single day observationCompare RV/TLC\[%-pred.\] of BO Patients with a healthy control group
DLCO [%-pred.]single day observationCompare difffusion capacity of the lung for CO \[%-pred.\] of BO Patients with a healthy control group
Lung clearance index (LCI)single day observationDetermine Lung clearance index with the Oxygen washout method
IL-8 (pg/mlsingle day observationComparing IL-8 in Serum of patients with BO with a healthy control group
Il-17 (pg/ml)single day observationComparing IL-17 in Serum of patients with BO with a healthy control group
CrP (mg/dl)single day observationComparing CrP in Serum of patients with BO with a healthy control group
FeNO ppbsingle day observationComparing FeNO in exhaled air of patients with BO with a healthy control group
Sputum cell countsingle day observationComparing sputum cell counts of patients with BO with a healthy control group
IL-6 (pg/ml)single day observationComparing IL-6 in Serum of patients with BO with a healthy control group

Countries

Germany

Contacts

Primary ContactMartin Rosewich, MD
Martin.rosewich@kgu.de+49-69-6301

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026