Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04670627
Status:
COMPLETED
Last Update Posted:
2023-05-17
First Post:
2020-12-09
Brief Title:
Biomarkers in Nasal Samples of Seasonal Allergic Rhinitics
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Investigation of Molecular Biomarkers Associated With Occurrence of Seasonal Allergic Rhinitis AR In and Out of Active Allergy Season
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GSK AR ELF
Brief Summary:
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 individuals 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 coldflu swab will be collected at each study visit
Detailed Description:
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 participants 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None