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/AClinical Study ID
NCT04670627
19-2258
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
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
Connect with a study center
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United StatesSite Not Available

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