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

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ClinicalTrials.gov Identifier: NCT00585364
Recruitment Status : Completed
First Posted : January 3, 2008
Last Update Posted : February 15, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jay Kolls, University of Pittsburgh

Tracking Information
First Submitted Date January 1, 2008
First Posted Date January 3, 2008
Last Update Posted Date February 15, 2016
Study Start Date March 2005
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 1, 2008)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 1, 2008)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mechanisms of Immune Tolerance and Inflammation in Patients With Cystic Fibrosis With 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
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen 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.
Sampling Method Non-Probability Sample
Study Population 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.
Condition
  • Cystic Fibrosis
  • Allergic Bronchopulmonary Aspergillosis
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 12, 2016)
79
Original Estimated Enrollment
 (submitted: January 1, 2008)
300
Actual Study Completion Date December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00585364
Other Study ID Numbers SCCOR
P50HL084932 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: This was an observational trial that involved no device or drug.
Responsible Party Jay Kolls, University of Pittsburgh
Study Sponsor University of Pittsburgh
Collaborators National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Jay K Kolls, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date February 2016