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Clinical Validation of Birch Pollen in the EEU

NCT02351830 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2015-04-21

No results posted yet for this study

Summary

The EEU has proven effective in multiple studies evaluating various aspects of seasonal allergic rhinitis. All previous EEU clinical trials have utilized ragweed or grass pollen as the allergen of choice for dispersal, due to the local population, but many emerging treatments for allergic rhinitis are allergen specific, thus it is desirable to expand the repertoire of pollen selection for use in the EEU. Ragweed, grass and birch pollen have differing appearances and sizes but essentially, both have characteristics which promote the ability to keep the pollen grains suspended and hence, the ability to maintain proper concentrations within the EEU. Preliminary validation studies conducted in the EEU, absent of human volunteers, have confirmed our ability to release, disperse and maintain birch pollen concentrations in the EEU using the existing technology.

This study aims to validate the use of birch pollen on a clinical scale. By adding non- allergic participants into the EEU, the investigators hope to determine if non-allergic persons exhibit differences at baseline in their "epigenetic biomarkers" from those who have pre-existing and established allergic airways inflammation.

Conditions

  • Allergic Rhinitis

Interventions

OTHER

Birch Pollen

Participants will be exposed to birch pollen to activate their allergy symptoms therefore validating the unit.

PROCEDURE

Nasal Brushing

To assess allergic biomarkers participants will provide a nasal sample which will be collected using a cytobrush. This procedure will be performed twice; once at screening and once following pollen exposure in the EEU.

Sponsors & Collaborators

  • University of British Columbia

    collaborator OTHER

  • Queen's University

    lead OTHER

Principal Investigators

  • Anne K Ellis, MD · Queen's University

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02351830 on ClinicalTrials.gov