Biomarkers in Nasal Samples of Seasonal Allergic Rhinitics (GSK AR ELF)

  • STATUS
    Recruiting
  • End date
    Jun 11, 2023
  • participants needed
    50
  • sponsor
    University of North Carolina, Chapel Hill
Updated on 11 August 2022
Accepts healthy volunteers

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.

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.

Details
Condition Seasonal Allergic Rhinitis, Rhinovirus
Clinical Study IdentifierNCT04670627
SponsorUniversity of North Carolina, Chapel Hill
Last Modified on11 August 2022

Eligibility

Yes No Not Sure

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 mm
than negative control), AND History of physician-diagnosed seasonal allergic rhinitis, OR
Symptoms 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 been
informed of all pertinent aspects of the study before any assessment is performed
(Non-allergic)
Non-smoking males and females aged 18-70 years, inclusive
Willing and able to comply with scheduled visits, nasal sample collection, and other
study procedures
Negative results to a panel of aeroallergens via skin prick testing
No history of physician-diagnosed allergic rhinitis and no history of seasonal runny
nose,nasal congestion, sneezing or nasal pruritis
Willingness to undergo written informed consent indicating that the participant has
been informed of all pertinent aspects of the study before any assessment is
performed
Willing and able to comply with scheduled visits, nasal sample collection, and other
study procedures

Exclusion Criteria

Symptomatic perennial AR (for example, allergy to dust mite or pet dander causing
year-round symptoms)
A subject who is breastfeeding
Use of immunosuppressive medications such as daily systemic corticosteroids; in
addition, participants who have used systemic corticosteroids in the past 3 months
Subjects diagnosed with autoimmune diseases
will not be enrolled
Use of other medications or supplements that may interfere with interpretation of
Subjects with an upper respiratory tract infection within the previous 4 weeks
outcomes
Subjects with known nasal polyps
Presence of other diagnoses such as non-allergic rhinitis, chronic sinusitis, etc
Subjects with known history of HIV or hepatitis virus
that in the opinion of the study investigator or medically qualified designee may
A subject who has previously been enrolled in this study
affect interpretation of the data or subjects' ability to safely participate in the
A subject whose gender identity is different from their birth-assigned sex
study
A subject who is an employee of the investigational site and either directly involved
in the conduct of the study or a member of their immediate family; or an employee of
the investigational site otherwise supervised by the investigator; or, a GSK employee
directly 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 (or
as determined by the local requirement) or 5 half-lives preceding the first dose of
investigational 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 during
study participation
A subject with, in the opinion of the investigator or medically qualified designee, an
acute or chronic medical or psychiatric condition or laboratory abnormality that may
increase the risk associated with study participation or may interfere with the
interpretation of study results and, in the judgment of the investigator or medically
qualified 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 the
study
Use of tobacco or nicotine products, including electronic cigarettes. A subject who
in the opinion of the investigator or medically qualified designee, should not
participate in the study
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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