CompletedNot Applicable

Biomarkers in Nasal Samples of Seasonal Allergic Rhinitics

United States92 participantsStarted 2021-03-22

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 ex…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Eosinophilic Cationic Protein (ECP) in Nasal Epithelial Lining Fluid (NELF) in ng/mL

Timeframe: Up to 15 months

Immunoglobulin E (IgE) in NELF in kU/L

Timeframe: Up to15 months

Trial details

NCT IDNCT04670627

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-04-27

View on ClinicalTrials.gov More Seasonal Allergic Rhinitis trials