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Bronchial Inflammation of Small Airways in Patients With Cystic Fibrosis

NCT01479166 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2014-10-29

No results posted yet for this study

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

Sponsors & Collaborators

  • Johann Wolfgang Goethe University Hospital

    lead OTHER

Principal Investigators

  • Stefan Zielen, MD, PhD · Children´s Hospital of Johann Wolfgang Goethe-Univeristy, Frankfurt/Main

Eligibility

Min Age
6 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01479166 on ClinicalTrials.gov