Clinical Trials Logo

Clinical Trial 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 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.


Clinical Trial 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 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 Design


Related Conditions & MeSH terms


NCT number NCT04670627
Study type Observational
Source University of North Carolina, Chapel Hill
Contact
Status Completed
Phase
Start date March 22, 2021
Completion date April 27, 2023

See also
  Status Clinical Trial Phase
Terminated NCT01337323 - Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting N/A
Completed NCT01171664 - Clinical Trial of STAHIST in Seasonal Allergic Rhinitis (SAR) Subjects Phase 2
Completed NCT00784732 - A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber Phase 2
Completed NCT00578929 - Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients Phase 3
Completed NCT00619827 - Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract Phase 1
Completed NCT00209365 - The Role of Pollen Starch Granules in Pollen Challenge Studies in the Fraunhofer Environmental Exposure Unit N/A
Terminated NCT00223587 - Seasonal Allergic Rhinitis and Driving Ability Phase 4
Completed NCT00637455 - Single Center, Randomized, Double-Blind,Crossover Study Comparing Effects Of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel Phase 4
Completed NCT00963599 - Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117) Phase 3
Recruiting NCT05346718 - Threshold Concentrations for Ragweed and Birch Pollen in Seasonal Allergic Rhinitis N/A
Completed NCT06126952 - Azelastine Allergen Chamber - Onset of Action Study Phase 2
Completed NCT01940146 - Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis Phase 2
Completed NCT02245360 - Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis Phase 3
Completed NCT01230619 - Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis Phase 2
Completed NCT00574210 - PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm) Phase 2
Completed NCT00561717 - A Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of a Nasal Spray in Allergen Induced Seasonal Allergic Rhinitis Phase 4
Completed NCT00405899 - Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections N/A
Completed NCT00420082 - A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber Phase 2
Completed NCT00443495 - Phase I/IIa Study on Chitin Microparticles in Subjects Suffering From Allergic Rhinitis Phase 1/Phase 2
Completed NCT03097432 - Non-interventional Study to Assess the Tolerability, the Safety Profile and the Adherence of Different Up-dosing Schemes for a Sublingual Immunotherapy Treatment N/A