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Completed

NCT Number: NCT00585364

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

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.

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Key information

Conditions

Cystic Fibrosis Allergic Bronchopulmonary Aspergillosis Aspergillosis Aspergillosis, Allergic Bronchopulmonary Bacterial Infections and Mycoses Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infant, Newborn, Diseases Infections Lung Diseases Lung Diseases, Fungal Mycoses Pancreatic Diseases Pulmonary Aspergillosis Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study 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

Acronym: ABPA

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Jan 3, 2008
Registry last updated
Feb 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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