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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seasonal Allergic Rhinitics | Non-smoking males and females aged 18-70 years, inclusive with 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. | ||
| Control | Non-smoking males and females aged 18-70 years, inclusive with 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Eosinophilic Cationic Protein (ECP) in Nasal Epithelial Lining Fluid (NELF) in ng/mL | NELF will be collected from volunteers with a history of seasonal allergic rhinitis. ECP concentration in NELF (ng/mL) will be compared between samples obtained during symptomatic periods (during their relevant allergy season) vs those obtained during asymptomatic periods | Up to 15 months |
| Immunoglobulin E (IgE) in NELF in kU/L | NELF will be collected from volunteers with a history of seasonal allergic rhinitis. IgE concentration in NELF (ku/L) will be compared between samples obtained during symptomatic periods (during their relevant allergy season) vs those obtained during asymptomatic periods | Up to15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Virus Detection in Nasopharyngeal Swabs | Nasopharyngeal swabs will be performed on volunteers with a history of seasonal allergic rhinitis during symptomatic periods (during their relevant allergy season) and during asymptomatic periods. The percentage of samples containing detectable respiratory virus by Polymerase Chain Reaction (PCR) analysis will be calculated. | Up to 15 months |
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Inclusion Criteria:
(Allergic Rhinitics):
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.
(Non-allergic):
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Neil Alexis, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26206871 | Background | Gauvreau GM, El-Gammal AI, O'Byrne PM. Allergen-induced airway responses. Eur Respir J. 2015 Sep;46(3):819-31. doi: 10.1183/13993003.00536-2015. Epub 2015 Jul 23. | |
| 17441789 | Background | Arvidsson MB, Lowhagen O, Rak S. Early and late phase asthmatic response in lower airways of cat-allergic asthmatic patients--a comparison between experimental and environmental allergen challenge. Allergy. 2007 May;62(5):488-94. doi: 10.1111/j.1398-9995.2007.01278.x. |
| Label | URL |
|---|---|
| Allergies and Hay Fever U.S. Data | View source |
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Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
9-36 months following publication
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| Ratio of NELF IgE (kU/L) to Peripheral blood IgE (kU/L) | NELF samples and peripheral blood samples will be obtained at Visit 1. The ratio of IgE in NELF to IgE in peripheral blood will be calculated. | Up to 15 months |
| Tryptase in NELF in ng/mL | NELF will be collected from volunteers with a history of seasonal allergic rhinitis. Tryptase concentration in NELF (ng/mL) will be compared between samples obtained during symptomatic periods (during their relevant allergy season) vs those obtained during asymptomatic periods | Up to 15 months |
| Inflammatory Cytokines in NELF in pg/mL | NELF will be collected from volunteers with a history of seasonal allergic rhinitis. Inflammatory cytokines in NELF (pg/mL) will be compared between samples obtained during symptomatic periods (during their relevant allergy season) vs those obtained during asymptomatic periods | Up to 15 months |
| 9215248 | Background | Sicherer SH, Wood RA, Eggleston PA. Determinants of airway responses to cat allergen: comparison of environmental challenge to quantitative nasal and bronchial allergen challenge. J Allergy Clin Immunol. 1997 Jun;99(6 Pt 1):798-805. doi: 10.1016/s0091-6749(97)80014-0. |
| 17950857 | Background | Wenzel S, Wilbraham D, Fuller R, Getz EB, Longphre M. Effect of an interleukin-4 variant on late phase asthmatic response to allergen challenge in asthmatic patients: results of two phase 2a studies. Lancet. 2007 Oct 20;370(9596):1422-31. doi: 10.1016/S0140-6736(07)61600-6. |
| 29137638 | Background | Deschildre A, Pichavant M, Engelmann I, Langlois C, Drumez E, Pouessel G, Boileau S, Romero-Cubero D, Decleyre-Badiu I, Dewilde A, Hober D, Neve V, Thumerelle C, Lejeune S, Mordacq C, Gosset P. Virus-triggered exacerbation in allergic asthmatic children: neutrophilic airway inflammation and alteration of virus sensors characterize a subgroup of patients. Respir Res. 2017 Nov 14;18(1):191. doi: 10.1186/s12931-017-0672-0. |
| 27474123 | Background | Kantor DB, Stenquist N, McDonald MC, Schultz BJ, Hauptman M, Smallwood CD, Nelson KA, Perzanowski MS, Matsui EC, Phipatanakul W, Hirschhorn JN. Rhinovirus and serum IgE are associated with acute asthma exacerbation severity in children. J Allergy Clin Immunol. 2016 Nov;138(5):1467-1471.e9. doi: 10.1016/j.jaci.2016.04.044. Epub 2016 Jun 15. No abstract available. |
| 10453026 | Background | Jaovisidha P, Peeples ME, Brees AA, Carpenter LR, Moy JN. Respiratory syncytial virus stimulates neutrophil degranulation and chemokine release. J Immunol. 1999 Sep 1;163(5):2816-20. |
| 28011618 | Background | Rebuli ME, Speen AM, Clapp PW, Jaspers I. Novel applications for a noninvasive sampling method of the nasal mucosa. Am J Physiol Lung Cell Mol Physiol. 2017 Feb 1;312(2):L288-L296. doi: 10.1152/ajplung.00476.2016. Epub 2016 Dec 23. |
| 8360397 | Background | Kaulbach HC, White MV, Igarashi Y, Hahn BK, Kaliner MA. Estimation of nasal epithelial lining fluid using urea as a marker. J Allergy Clin Immunol. 1993 Sep;92(3):457-65. doi: 10.1016/0091-6749(93)90125-y. |
| 31557636 | Background | Southworth T, Pattwell C, Khan N, Mowbray SF, Strieter RM, Erpenbeck VJ, Singh D. Increased type 2 inflammation post rhinovirus infection in patients with moderate asthma. Cytokine. 2020 Jan;125:154857. doi: 10.1016/j.cyto.2019.154857. Epub 2019 Sep 23. |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |