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

This study has been completed.
Sponsor:
Collaborators:
Children's Hospital of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jay Kolls, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00585364
First received: January 1, 2008
Last updated: February 12, 2016
Last verified: February 2016

January 1, 2008
February 12, 2016
March 2005
December 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00585364 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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.
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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
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.
Non-Probability Sample
Male and female subjects with CF who have A. fumigatus in cultures of 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.
  • Cystic Fibrosis
  • Allergic Bronchopulmonary Aspergillosis
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
79
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
6 Years and older   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00585364
SCCOR, P50HL084932
No
No
This was an observational trial that involved no device or drug.
Jay Kolls, University of Pittsburgh
University of Pittsburgh
  • Children's Hospital of Pittsburgh
  • National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Jay K Kolls, MD University of Pittsburgh
University of Pittsburgh
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP