Mechanisms of Immune Tolerance and Inflammation in Patients With Cystic Fibrosis With ABPA - Full Text View

Sponsors and Collaborators:	University of Pittsburgh Children's Hospital of Pittsburgh National Institutes of Health (NIH)
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00585364

Purpose

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 cause them to wheeze, cough, or have 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.

Condition
Cystic Fibrosis Allergic Bronchopulmonary Aspergillosis

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis Molds

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
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

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

The CF subject's blood will be processed to establish a cell line (lymphocyte transformation) for a source of DNA for future genetic studies.

Estimated Enrollment:	300
Study Start Date:	March 2005
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
CF (non-ABPA) cystic fibrosis and culture positive for A. fumigatus in airway cultures.
CF and ABPA cystic fibrosis and diagnosis of ABPA
healthy control healthy non-CF

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Male and female subjects with CF who have A. fumigatus in cultures of their airway flora and receive clinical care at the Antonio J. and Janet Palumbo Cystic Fibrosis Center at Children's Hospital of Pittsburgh. Age (± 1 year) and sex matched healthy, non CF controls will also be recruited.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585364

Contacts

Contact: Elizabeth R Hartigan, MPH, RN	412-692-7060	elizabeth.hartigan@chp.edu
Contact: Adrienne Horn, BSN, RN	412-692-8069	adrienne.horn@chp.edu

Locations

United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Elizabeth R Hartigan, MPH, RN 412-692-7060 elizabeth.hartigan@chp.edu
Principal Investigator: Jay K Kolls, MD
Sub-Investigator: James Kreindler, MD
Sub-Investigator: Anuradha Ray, PhD
Sub-Investigator: Yatin Vyas, MD
Sub-Investigator: Patricia Dubin, MD
Sub-Investigator: David M Orenstein, MD
Sub-Investigator: Timothy Murphy, MD
Sub-Investigator: Jonathan D Finder, MD
Sub-Investigator: Joseph M Pilewski, MD
Sub-Investigator: Shean Aujla, MD
Sub-Investigator: Joel H Weinberg, MD
Sub-Investigator: Geoffrey Kurland, MD
Sub-Investigator: Todd Green, MD

Sponsors and Collaborators

University of Pittsburgh

Children's Hospital of Pittsburgh

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Jay K Kolls, MD

University of Pittsburgh

More Information

Responsible Party:	University of Pittsburgh ( Jay K. Kolls, MD )
Study ID Numbers:	SCCOR, HL-05-009
Study First Received:	January 1, 2008
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00585364
Health Authority:	United States: Federal Government

Keywords provided by University of Pittsburgh:

Allergic Bronchopulmonary Aspergillosis
Aspergillus fumigatus
cytokine expression

Study placed in the following topic categories:

Allergic bronchopulmonary aspergillosis
Aspergillosis, Allergic Bronchopulmonary
Fibrosis
Aspergillosis
Inflammation
Mycoses
Hypersensitivity
Digestive System Diseases
Genetic Diseases, Inborn
Cystic Fibrosis

Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases
Hypersensitivity, Immediate
Infant, Newborn, Diseases
Pancreatic Diseases
Cystic fibrosis
Lung Diseases, Fungal
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Pathologic Processes
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009