Biomarkers in Nasal Samples of Seasonal Allergic Rhinitics

NCT04670627 | Completed

• 1 other identifier: 19-2258
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Allergic Rhinitis; Rhinovirus

Keywords

Seasonal Allergies

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Respiratory Virus Detection in Nasopharyngeal Swabs

  Up to 15 months

• Ratio of NELF IgE (kU/L) to Peripheral blood IgE (kU/L)

  Up to 15 months

• Tryptase in NELF in ng/mL

  Up to 15 months

• Inflammatory Cytokines in NELF in pg/mL

  Up to 15 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (10)

• 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.

  PMID: 26206871 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.

  PMID: 17441789 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.

  PMID: 9215248 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.

  PMID: 17950857 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.

  PMID: 29137638 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.

  PMID: 27474123 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.

  PMID: 10453026 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.

  PMID: 28011618 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.

  PMID: 8360397 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.

  PMID: 31557636 BACKGROUND

Related Links

• Allergies and Hay Fever U.S. Data

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Neil Alexis, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 17, 2020
• Study Start: March 22, 2021
• Primary Completion: April 27, 2023
• Study Completion: April 27, 2023
• Last Updated: May 17, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 9-36 months following publication

Locations

US (1)