Bronchial Inflammation of Small Airways in Patients With Cystic Fibrosis (FRA-MUKO)
|ClinicalTrials.gov Identifier: NCT01479166|
Recruitment Status : Completed
First Posted : November 24, 2011
Last Update Posted : October 29, 2014
In the planned study, 60 patients with mild cystic fibrosis (CF) with and without the involvement of small airways (small airway disease - SAD) are to be compared with a historical control group matched in age and gender. During the first study visit subjects are asked to perform a pulmonary function test (spirometry, body plethysmography with helium, determination of "Trapped Air") and exhaled nitric oxide (eNO) and exhaled carbon monoxide (eCO) measurements will be done in exhaled air. In addition, a blood sample is drawn to describe inflammatory status. Sputum is induced as well. During the second study visit, a non-specific bronchial provocation test(methacholine PD20 FEV1) is performed.
The aim of the study is to get a characterization of the bronchial and systemic inflammation (IL-1ß, IL-6, IL-8, IL-17, TNF-α, NFKB, and recognition structures like TLR2 and TLR4) in CF patients with and without the involvement of the small airways, which may point to new treatment strategies.
|Condition or disease|
Aim of this study is the characterization of patients with mild cystic fibrosis in terms of lung function, bronchial hyperreactivity and the degree of systemic and bronchial inflammation.
Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction(qRT-PCR) and by cytometric bead assay (CBA). Components of the innate immune system (mannose-binding protein, TLR recognition proteins and surfactant proteins) are genetically determined from sputum or blood respectively. In order to support the analyzed lung function and sputum/ serum biomarker data the investigators will also rely on pre-existing imaging data like chest x-rays or high-resolution computer tomography (HRCT)of the lungs.
Methods and Work Programme:
This study consists of two study visits (V1 and V2)
Measurement of nitric oxide in exhaled air (eNO) Measurement of carbon monoxide in exhaled air (eCO) 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
Unspecific bronchial provocation test with methacholine (PD20 FEV1 methacholine) Lung function testing with spirometry and body plethysmography
CF Children and adults (6 - 60 years of age) and a healthy control group (6-60 years of age). Both patients and healthy subjects are recruited from the Christiane Herzog Cystic fibrosis outpatient clinic.
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Observational Model:||Case Control|
|Official Title:||Bronchial Inflammation of Small Airways in Patients With Cystic Fibrosis|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
affected patients with small airway disease (SAD)
20 patients suffering from mild cystic fibrosis and involvement of small airways
affected patients without small airway disease (SAD)
20 patients suffering from mild cystic fibrosis without SAD
20 matched controls not suffering from cystic fibrosis
- Bronchial Inflammation in sputum of patients with CF [ Time Frame: 24 months ]Measuring IL-8 in induced sputum compared to induced sputum of age matched controls
- Inflammatory proteins like (Il-1,IL-6, TNF alpha) in induced sputum [ Time Frame: 24 months ]Measuring secondary parameters in induced sputum by cytometric bead assay
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479166
|Children's Hospital, Johann Wolfgang Goethe-University|
|Frankfurt am Main, Hesse, Germany, 60590|
|Principal Investigator:||Stefan Zielen, MD, PhD||Children´s Hospital of Johann Wolfgang Goethe-Univeristy, Frankfurt/Main|