Bronchial Inflammation of Small Airways in Patients With Cystic Fibrosis

NCT01479166 | Completed

• 1 other identifier: 85/11
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis; HRCT; Sputum; Blood; Inflammation; adaptive immune system; innate immune system

Outcome Measures

Primary Outcomes (1)

• Bronchial Inflammation in sputum of patients with CF

  Measuring IL-8 in induced sputum compared to induced sputum of age matched controls

  24 months

Secondary Outcomes (1)

• Inflammatory proteins like (Il-1,IL-6, TNF alpha) in induced sputum

  24 months

Study Arms (3)

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

Eligibility Criteria

• Age: 6 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead

Study Sites (1)

Children's Hospital, Johann Wolfgang Goethe-University

Frankfurt am Main, Hesse, 60590, Germany

Location

Related Publications (2)

• Eickmeier O, Huebner M, Herrmann E, Zissler U, Rosewich M, Baer PC, Buhl R, Schmitt-Grohe S, Zielen S, Schubert R. Sputum biomarker profiles in cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD) and association between pulmonary function. Cytokine. 2010 May;50(2):152-7. doi: 10.1016/j.cyto.2010.02.004. Epub 2010 Feb 23.

  PMID: 20181491 BACKGROUND

• Tiddens HA, Donaldson SH, Rosenfeld M, Pare PD. Cystic fibrosis lung disease starts in the small airways: can we treat it more effectively? Pediatr Pulmonol. 2010 Feb;45(2):107-17. doi: 10.1002/ppul.21154.

  PMID: 20082341 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum and Sputum

MeSH Terms

Conditions

Cystic Fibrosis; Inflammation

Condition Hierarchy (Ancestors)

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

Study Officials

• Stefan Zielen, MD, PhD

  Children´s Hospital of Johann Wolfgang Goethe-Univeristy, Frankfurt/Main

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. med. Stefan Zielen

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: November 24, 2011
• Study Start: June 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: October 29, 2014

Record last verified: 2014-10

Locations

DE (1)