Nasal Epithelial Cells/Blood Lymphocyte Markers for CF/CF Pulmonary Exacerbations
Recruitment status was Not yet recruiting
Study Hypothesis: We hypothesize that cellular markers from nasal epithelial cells and blood lymphocytes can serve as potential biomarkers reflect the underlying inflammatory state of the lung and will be helpful in determining the presence of a CF pulmonary exacerbation and its overall severity.
|Study Design:||Observational Model: Defined Population
Time Perspective: Longitudinal
|Official Title:||Use of Nasal Epithelial Cells and Blood Lymphocytes to Identify Markers for Cystic Fibrosis and Cystic Fibrosis Pulmonary Exacerbations|
|Study Start Date:||September 2006|
|Estimated Study Completion Date:||September 2007|
CF is the most common lethal genetic disease in the US afflicting approximately 30,000 people. Chronic disease of the respiratory tract, which is responsible for early death, affects both the upper and lower airways.
We propose to utilize cells (blood lymphocytes and nasal epithelial cells) that are readily accessible and are known to express CFTR and therefore candidates to express markers of the downstream consequences of CFTR deficiency.
A marker that indicates the inflammatory state of the lung would be useful to identify infective/inflammatory exacerbations as opposed to worsening due to pulmonary vascular disease or simply upper airway infection. This marker might help to guide therapy for intensity and duration. Evidence in mice suggest that lymphocytes may be a driving force for inflammation in the CF lung, particularly during exacerbations, and also that human CF lymphocytes have dysfunctional production of cytokines.
To identify markers in nasal epithelial cells or blood lymphocytes that distinguish CF patients from those with functional CFTR (healthy volunteers and patients with asthma). If successful this could become a marker for CFTR correction by drugs or other systemic therapies.
To identify markers in blood lymphocytes that will identify inflammatory status (ie, distinguish an active exacerbation from return to clinical stability) in CF patients. This could become a marker for infectious exacerbations of CF airway disease.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00381628
|Contact: James F Chmiel, MD, MPHfirstname.lastname@example.org|
|Contact: Kate Hilliard, CCRCemail@example.com|
|United States, Ohio|
|Rainbow Babies and Children's Hospital||Not yet recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: James F Chmiel, MD, MPH 216-844-3267 firstname.lastname@example.org|
|Principal Investigator: James F Chmiel, MD, MPH|
|Principal Investigator:||James F Chmiel, MD, MPH||University Hospital Case Medical Center|