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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Children's Hospital of Pittsburgh
National Institutes of Health (NIH)
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00585364
First received: January 1, 2008
Last updated: January 12, 2010
Last verified: January 2010
History of Changes
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: 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

Resource links provided by NLM:

U.S. FDA Resources

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

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 Study Completion Date: December 2012
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

No publications provided

Responsible Party: Jay K. Kolls, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00585364     History of Changes
Other Study ID Numbers: SCCOR, HL-05-009
Study First Received: January 1, 2008
Last Updated: January 12, 2010
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Allergic Bronchopulmonary Aspergillosis
Aspergillus fumigatus
cytokine expression

Additional relevant MeSH terms:
Aspergillosis, Allergic Bronchopulmonary
Pulmonary Aspergillosis
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases
Immune System Diseases
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
 Aspergillosis
Cystic Fibrosis
Fibrosis
Inflammation
Mycoses
Respiratory Hypersensitivity
Respiratory Tract Infections
Hypersensitivity, Immediate
Hypersensitivity
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013