Seasonal Allergic RhinitisGSK AR ELFNCT04670627
Biomarkers in Nasal Samples of Seasonal Allergic Rhinitics
An observational study of Seasonal Allergic Rhinitis and Rhinovirus, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Seasonal Allergic Rhinitis, Rhinovirus
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2021to 27 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- (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.
Show all 13Show fewer
- 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.
Who cannot join
- 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)
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Investigation of Molecular Biomarkers Associated With Occurrence of Seasonal Allergic Rhinitis (AR) In and Out of Active Allergy Season
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.
Read the 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.
- Conditions
- Seasonal Allergic Rhinitis, Rhinovirus
- Keywords
- Seasonal Allergies
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to15 months
Secondary outcomes (4)
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.
Measured: Up to 15 months
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.
Measured: 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
Measured: 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
Measured: Up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start22 Mar 2021
- Primary completion27 Apr 2023
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Neil Alexis, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670627
- Sponsor's protocol ID
- 19-2258
- Acronym
- GSK AR ELF
- Status last verified
- Jul 2022
- First submitted
- 9 Dec 2020
- Last updated
- 17 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 26206871Arvidsson 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.
PubMed 17441789Sicherer 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.
PubMed 9215248Wenzel 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.
PubMed 17950857Deschildre 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.
PubMed 29137638Kantor 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.
PubMed 27474123Jaovisidha 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.
PubMed 10453026Rebuli 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.
PubMed 28011618Kaulbach 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.
PubMed 8360397Southworth 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.
PubMed 31557636
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Molecular Biomarkers Associated With Occurrence of Seasonal Allergic Rhinitis (AR) In and Out of Active Allergy Season
- ClinicalTrials.gov ID
- NCT04670627
- Acronym / sponsor ID
- GSK AR ELF / 19-2258
- Conditions
- Seasonal Allergic Rhinitis, Rhinovirus
- Keywords
- Seasonal Allergies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Eosinophilic Cationic Protein (ECP) in Nasal Epithelial Lining Fluid (NELF) in ng/mL
Time frame: Up to 15 months
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
Immunoglobulin E (IgE) in NELF in kU/L
Time frame: Up to15 months
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
4 secondary outcomes
Respiratory Virus Detection in Nasopharyngeal Swabs
Time frame: Up to 15 months
Ratio of NELF IgE (kU/L) to Peripheral blood IgE (kU/L)
Time frame: Up to 15 months
Tryptase in NELF in ng/mL
Time frame: Up to 15 months
Inflammatory Cytokines in NELF in pg/mL
Time frame: Up to 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Background: PubMed 26206871Gauvreau 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.
- Background: PubMed 17441789Arvidsson 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.
- Background: PubMed 9215248Sicherer 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.
- Background: PubMed 17950857Wenzel 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.
- Background: PubMed 29137638Deschildre 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.
- Background: PubMed 27474123Kantor 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.
- Background: PubMed 10453026Jaovisidha 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.
- Background: PubMed 28011618Rebuli 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.
- Background: PubMed 8360397Kaulbach 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.
- Background: PubMed 31557636Southworth 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Alexis, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seasonal Allergic Rhinitis and Rhinovirus, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eosinophilic Cationic Protein (ECP) in Nasal Epithelial Lining Fluid (NELF) in ng/mL (time frame: Up to 15 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04670627, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.