Status:
COMPLETED
Biomarkers in Nasal Samples of Seasonal Allergic Rhinitics
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Seasonal Allergic Rhinitis
Rhinovirus
Eligibility:
All Genders
18-70 years
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 indivi...
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 rhinit...
Eligibility Criteria
Inclusion
- (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.
- Willing and able to comply with scheduled visits, nasal sample collection, and other study 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 runny nose,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 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
- Symptomatic perennial AR (for example, allergy to dust mite or pet dander causing year-round symptoms)
- Use of immunosuppressive medications such as daily systemic corticosteroids; in addition, participants who have used systemic corticosteroids in the past 3 months will not be enrolled
- Use of other medications or supplements that may interfere with interpretation of outcomes
- Presence of other diagnoses such as non-allergic rhinitis, chronic sinusitis, etc. that in the opinion of the study investigator or medically qualified designee may affect interpretation of the data or subjects' ability to safely participate in the 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
- 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 not participate 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.
Key Trial Info
Start Date :
March 22 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 27 2023
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04670627
Start Date
March 22 2021
End Date
April 27 2023
Last Update
May 17 2023
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599