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Bronchial Inflammation of Small Airways in Patients With Cystic Fibrosis (FRA-MUKO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stefan Zielen, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01479166
First received: November 22, 2011
Last updated: October 28, 2014
Last verified: October 2014
  Purpose

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
Cystic Fibrosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Bronchial Inflammation of Small Airways in Patients With Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Bronchial Inflammation in sputum of patients with CF [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Measuring IL-8 in induced sputum compared to induced sputum of age matched controls


Secondary Outcome Measures:
  • Inflammatory proteins like (Il-1,IL-6, TNF alpha) in induced sputum [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Measuring secondary parameters in induced sputum by cytometric bead assay


Biospecimen Retention:   Samples With DNA

whole blood, serum and Sputum


Enrollment: 20
Study Start Date: June 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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
non-affected patients
20 matched controls not suffering from cystic fibrosis

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study is carried out in CF children and adults (6 to 60 years) and healthy controls (6-60 years). Both patients (40) and healthy subjects (20) are recruited from the Christiane Herzog CF outpatient clinic of Johann Wolfgang Goethe-University, Frankfurt/M, Germany.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479166

Locations
Germany
Children's Hospital, Johann Wolfgang Goethe-University
Frankfurt am Main, Hesse, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Stefan Zielen, MD, PhD Children´s Hospital of Johann Wolfgang Goethe-Univeristy, Frankfurt/Main
  More Information

Publications:
Responsible Party: Stefan Zielen, Professor Dr. med. Stefan Zielen, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01479166     History of Changes
Other Study ID Numbers: 85/11
Study First Received: November 22, 2011
Last Updated: October 28, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
cystic fibrosis
HRCT
Sputum
Blood
Inflammation
adaptive immune system
innate immune system

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Inflammation
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014