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

Tracking Information

First Received Date ^ICMJE

January 1, 2008

Last Updated Date

January 12, 2010

Start Date ^ICMJE

March 2005

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00585364 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

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 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.

Condition ^ICMJE

Cystic Fibrosis
Allergic Bronchopulmonary Aspergillosis

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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 ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

December 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00585364

Other Study ID Numbers ^ICMJE

SCCOR, HL-05-009

Has Data Monitoring Committee

Responsible Party

Jay K. Kolls, MD, University of Pittsburgh

Study Sponsor ^ICMJE

University of Pittsburgh

Collaborators ^ICMJE

Children's Hospital of Pittsburgh
National Institutes of Health (NIH)

Investigators ^ICMJE

Principal Investigator:

Jay K Kolls, MD

University of Pittsburgh

Information Provided By

University of Pittsburgh

Verification Date

January 2010

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

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