The purpose of this study is to analyze nasal samples for the presence of biomarkers of allergic inflammation as well as cold and flu infections, and compare these samples both in and out of an individual's active allergy season. 40 subjects who suffer from seasonal allergies will be recruited and seen both in and out of allergy season, and 10 healthy controls. Nasal epithelial lining fluid (NELF,) collected by placing small filter papers into the nostrils, blood for analysis and a cold/flu swab will be collected at each study visit.
This is an observational study of adults with and without seasonal allergic rhinitis (AR). Fifty volunteers; 40 with a history of seasonal allergic rhinitis and 10 without a history of allergic rhinitis will be recruited for this study. After screening for eligibility and undergoing informed consent a focused medical history, medication review, and physical exam by the study physician will be performed. An allergic rhinitis questionnaire will be completed by the participant. This will be followed by allergy skin prick testing to a panel of common aeroallergens, collection of NELF samples, a nasal swab and venipuncture. For the non-allergic participants, this will conclude participation in the study. Participants with seasonal allergic rhinitis who completed the first study visit outside of the participant's typical allergy season will return for the second study visit during allergy season, and vice versa for participants presenting for the first study visit during allergy season. For example, a participant with a history of symptomatic allergic rhinitis triggered by tree pollen would attend one study visit during tree pollen season (March-May) and a second study visit outside of allergy season while asymptomatic, a least one month from the first study visit. Participants who suffer from grass pollen allergies would attend the "in-season" study visit during the months of June-August, and participants suffering from weed pollen allergies would attend the "in-season" study visit during the months of September-November. Participants who suffer from allergic rhinitis symptoms related to trees and weeds, but not grass, would attend the "in-season" visit either during March-May or during September-November. For those same participants, the "off-season" visit would occur either during June-August or during December-February. For each outcome measure, measurements obtained from allergic rhinitics during allergy season and measurements obtained outside of allergy season will be compared. Measurements from samples taken from allergic rhinitics during and outside of allergy season will also be compared with non-allergic sample measurements.
Study Type
OBSERVATIONAL
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Eosinophilic Cationic Protein (ECP) in Nasal Epithelial Lining Fluid (NELF) in ng/mL
NELF will be collected from volunteers with a history of seasonal allergic rhinitis. ECP concentration in NELF (ng/mL) will be compared between samples obtained during symptomatic periods (during their relevant allergy season) vs those obtained during asymptomatic periods
Time frame: Up to 15 months
Immunoglobulin E (IgE) in NELF in kU/L
NELF will be collected from volunteers with a history of seasonal allergic rhinitis. IgE concentration in NELF (ku/L) will be compared between samples obtained during symptomatic periods (during their relevant allergy season) vs those obtained during asymptomatic periods
Time frame: Up to15 months
Respiratory Virus Detection in Nasopharyngeal Swabs
Nasopharyngeal swabs will be performed on volunteers with a history of seasonal allergic rhinitis during symptomatic periods (during their relevant allergy season) and during asymptomatic periods. The percentage of samples containing detectable respiratory virus by Polymerase Chain Reaction (PCR) analysis will be calculated.
Time frame: Up to 15 months
Ratio of NELF IgE (kU/L) to Peripheral blood IgE (kU/L)
NELF samples and peripheral blood samples will be obtained at Visit 1. The ratio of IgE in NELF to IgE in peripheral blood will be calculated.
Time frame: Up to 15 months
Tryptase in NELF in ng/mL
NELF will be collected from volunteers with a history of seasonal allergic rhinitis. Tryptase concentration in NELF (ng/mL) will be compared between samples obtained during symptomatic periods (during their relevant allergy season) vs those obtained during asymptomatic periods
Time frame: Up to 15 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Enrollment
92
Inflammatory Cytokines in NELF in pg/mL
NELF will be collected from volunteers with a history of seasonal allergic rhinitis. Inflammatory cytokines in NELF (pg/mL) will be compared between samples obtained during symptomatic periods (during their relevant allergy season) vs those obtained during asymptomatic periods
Time frame: Up to 15 months