Clinical trial NCT04670627: Biomarkers in Nasal Samples of Seasonal Allergic Rhinitics
Official title: Investigation of Molecular Biomarkers Associated With Occurrence of Seasonal Allergic Rhinitis (AR) In and Out of Active Allergy Season
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Seasonal Allergic Rhinitis
Rhinovirus
Keywords: Seasonal Allergies
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2020-12-17
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the general population, including UNC students and employees, individuals who have participated in previous research studies, and other healthy adults living in the southeastern United States and willing and able.

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 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.

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 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.

Eligibility criteria: 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.
* 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 Criteria:

* 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.

Primary outcomes:
measure: Eosinophilic Cationic Protein (ECP) in Nasal Epithelial Lining Fluid (NELF) in ng/mL
timeFrame: Up to 15 months
measure: Immunoglobulin E (IgE) in NELF in kU/L
timeFrame: Up to15 months
Secondary outcomes:
measure: Respiratory Virus Detection in Nasopharyngeal Swabs
timeFrame: Up to 15 months
measure: Ratio of NELF IgE (kU/L) to Peripheral blood IgE (kU/L)
timeFrame: Up to 15 months
measure: Tryptase in NELF in ng/mL
timeFrame: Up to 15 months
measure: Inflammatory Cytokines in NELF in pg/mL
timeFrame: Up to 15 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Neil Alexis, PhD
role: PRINCIPAL_INVESTIGATOR
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