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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cystic Fibrosis Allergic Bronchopulmonary Aspergillosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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CF (non-ABPA)

cystic fibrosis and culture positive for A. fumigatus in airway cultures.

No interventions assigned to this group

CF and ABPA

cystic fibrosis and diagnosis of ABPA

No interventions assigned to this group

healthy control

healthy non-CF

No interventions assigned to this group

Eligibility Criteria

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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

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

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes