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

Completed

• Conditions: Cystic Fibrosis; Allergic Bronchopulmonary Aspergillosis

• Registration Number: NCT00585364
• Lead Sponsor: University of Pittsburgh

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 Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2008-01-01
• Study First Submitted QC: 2008-01-01
• Study First Posted: 2008-01-03
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-12
• Last Update Posted: 2016-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

(CF)

• diagnosis of CF
• age 6 years or older
• presence of A. fumigatus in culture of airway flora, or the presence of one or more of the diagnostic criteria for ABPA (Control)
• age and sex matched to CF population

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Exclusion Criteria

(CF)

• uncontrolled CF-related diabetes mellitus
• use of oral steroids at a dose ≥ 0.5 mg/kg/day
• history of lung transplantation
• pulmonary exacerbation as defined by requirement for use of intravenous antibiotics or need for hospitalization within the preceding 14 days.
• patients who have a diagnosis of HIV and have a CD4+ Tcell count below 500 cells/ml will be excluded (control)
• asthma

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	baseline, 6 month follow-up, ABPA exacerbation

Secondary Outcome Measures

Name	Time	Method
To test the hypothesis that T cells from CF patients with ABPA will have decreased adaptive regulatory function	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	baseline, 6 month follow-up, ABPA exacerbation

Trial Locations

Locations (1)

Children's Hospital of Pittsburgh of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States