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

SCCOR in Host Factors in Chronic Lung Diseases: Mechanisms of Immune Tolerance and Inflammation in Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients With Cystic Fibrosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00585364

Acronym

ABPA

Enrollment

Registered

2008-01-03

Start date

2005-03-31

Completion date

2010-12-31

Last updated

2016-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Bronchopulmonary Aspergillosis, Cystic Fibrosis

Keywords

Allergic Bronchopulmonary Aspergillosis, Aspergillus fumigatus, cytokine expression

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results