Bronchial Inflammation of Small Airways in Patients With Cystic Fibrosis

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Inflammation Lung Diseases Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

6 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital, Johann Wolfgang Goethe-University

Frankfurt am Main, Hesse, 60590, Germany

About this study

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)

V1:

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

V2:

Unspecific bronchial provocation test with methacholine (PD20 FEV1 methacholine) Lung function testing with spirometry and body plethysmography

Study population:

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

informed consent
confirmed diagnosis of CF (known mutations and/or sweat chloride test > 60mval/l)
age between 6 and 60 years
vital capacity > 75%
Ability to perform lung function tests and inhalation

Exclusion criteria

< 6 and > 60 years of age on the day of written informed consent
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

Treatment and study plan

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Acronym: FRA-MUKO

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Nov 24, 2011
Registry last updated: Oct 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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