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

Cystic Fibrosis Clinical Trial

— ABPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00585364
• Other study ID #: SCCOR
• Secondary ID: P50HL084932
• Status: Completed
• Phase: N/A
• First received: January 1, 2008
• Last updated: February 12, 2016
• Start date: March 2005
• Est. completion date: December 2010

Study information

• Verified date: February 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Allergic Bronchopulmonary Aspergillosis
• Aspergillosis
• Cystic Fibrosis
• Fibrosis
• Pulmonary Aspergillosis

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	Children's Hospital of Pittsburgh, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No