Clinical Trial: Mechanisms of Immune Tolerance and Inflammation in Patients With Cystic Fibrosis With ABPA

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: SCCOR in Host Factors in Chronic Lung Diseases: Mechanisms of Immune Tolerance and Inflammation in Allergic Bronchopulmonary Aspergillosis (ABPA

Brief Summary: The goal of this study is to identify the immunological factors that influence a patient's response to the presence of the fungus Aspergillus fumigatus (A. fumigatus) in the lungs. In patients with cystic fibrosis (CF), this fungus is not known to cause damage to the lungs, but some patients respond with an allergic reaction that may cause wheeze, cough, or difficulty breathing. Approximately 230 patients will be enrolled with an additional 60 people who do not have CF and who do not have a history of asthma to serve as a comparison group.

Detailed Summary: In this cohort the investigators will study blood T-cell responses to Aspergillus antigens to determine if patients with ABPA have greater type 2 responses as measured by IL-13 compared to CF or non-CF controls.
Sponsor: University of Pittsburgh

Current Primary Outcome: To test the hypothesis that the white blood cells of CF patients with ABPA will demonstrate increased inflammatory cytokine expression in response to binding of A. fumigatus antigens compared to white blood cells from non-ABPA patients. [ Time Frame: baseline, 6 month follow-up, ABPA exacerbation ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To test the hypothesis that T cells from CF patients with ABPA will have decreased adaptive regulatory function [ Time Frame: baseline, 6 month follow-up, ABPA exacerbation ]
  • To test the hypothesis that surface-bound TGF beta is critical for the development and maintenance of immune tolerance to A. fumigatus antigens [ Time Frame: baseline, 6 month follow-up, ABPA exacerbation ]


Original Secondary Outcome: Same as current

Information By: University of Pittsburgh

Dates:
Date Received: January 1, 2008
Date Started: March 2005
Date Completion:
Last Updated: February 12, 2016
Last Verified: February 2016