Biomarkers in Nasal Samples of Seasonal Allergic Rhinitics

Last updated: May 15, 2023
Sponsor: University of North Carolina, Chapel Hill
Overall Status: Completed

Phase

N/A

Condition

Common Cold

Rhinitis, Allergic, Perennial

Allergy

Treatment

N/A

Clinical Study ID

NCT04670627
19-2258
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

(Allergic Rhinitics):

  • Non-smoking males and females aged 18-70 years, inclusive
  • History of Seasonal Allergic Rhinitis defined by: Sensitization to at least one seasonal aeroallergen via skin prick testing (wheal =3 mmthan negative control), AND History of physician-diagnosed seasonal allergic rhinitis, ORSymptoms consistent with seasonal allergic rhinitis, such as runny nose, nasal congestion,sneezing, or nasal pruritis.
  • Have lived in the South Atlantic region (Virginia, North and South Carolina, Georgia,Alabama, Florida) for at least 1 year prior to study entry.
  • Willing to undergo written informed consent indicating that the participant has beeninformed of all pertinent aspects of the study before any assessment is performed.
  • Willing and able to comply with scheduled visits, nasal sample collection, and otherstudy procedures.

(Non-allergic):

  • Non-smoking males and females aged 18-70 years, inclusive
  • No history of physician-diagnosed allergic rhinitis and no history of seasonal runnynose,nasal congestion, sneezing or nasal pruritis.
  • Negative results to a panel of aeroallergens via skin prick testing
  • Willingness to undergo written informed consent indicating that the participant hasbeen informed of all pertinent aspects of the study before any assessment isperformed.
  • Willing and able to comply with scheduled visits, nasal sample collection, and otherstudy procedures.

Exclusion

Exclusion Criteria:

  • Symptomatic perennial AR (for example, allergy to dust mite or pet dander causingyear-round symptoms)
  • Use of immunosuppressive medications such as daily systemic corticosteroids; inaddition, participants who have used systemic corticosteroids in the past 3 monthswill not be enrolled
  • Use of other medications or supplements that may interfere with interpretation ofoutcomes
  • Presence of other diagnoses such as non-allergic rhinitis, chronic sinusitis, etc.that in the opinion of the study investigator or medically qualified designee mayaffect interpretation of the data or subjects' ability to safely participate in thestudy.
  • A subject who is an employee of the investigational site and either directly involvedin the conduct of the study or a member of their immediate family; or an employee ofthe investigational site otherwise supervised by the investigator; or, a GSK employeedirectly involved in the conduct of the study or a member of their immediate family
  • A subject who has received treatment with an investigational drug within 30 days (oras determined by the local requirement) or 5 half-lives preceding the first dose ofinvestigational product (whichever is longer)
  • A subject who has participated in other studies (including non-medicinal studies)involving investigational product(s) within 30 days prior to study entry and/or duringstudy participation.
  • A subject with, in the opinion of the investigator or medically qualified designee, anacute or chronic medical or psychiatric condition or laboratory abnormality that mayincrease the risk associated with study participation or may interfere with theinterpretation of study results and, in the judgment of the investigator or medicallyqualified designee, would make the subject inappropriate for entry into this study
  • A subject who is pregnant or intending to become pregnant over the duration of thestudy
  • A subject who is breastfeeding
  • Use of tobacco or nicotine products, including electronic cigarettes. A subject who,in the opinion of the investigator or medically qualified designee, should notparticipate in the study
  • Subjects diagnosed with autoimmune diseases
  • Subjects with an upper respiratory tract infection within the previous 4 weeks
  • Subjects with known nasal polyps
  • Subjects with known history of HIV or hepatitis virus
  • A subject who has previously been enrolled in this study
  • A subject whose gender identity is different from their birth-assigned sex.

Study Design

Total Participants: 92
Study Start date:
March 22, 2021
Estimated Completion Date:
April 27, 2023

Study 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.

Connect with a study center

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

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