Clinical Validation of Birch Pollen in the EEU
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

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.
    

Detailed description: 
      The Environmental Exposure Unit (EEU) is a controlled allergen challenge model of allergic
      rhinitis ('hayfever') that has been used extensively to study various anti-allergic
      therapies. The EEU is a unique, internationally recognized research facility that allows for
      the exposure of groups of as few as 5 to as many as 150 volunteers simultaneously to ambient
      levels of airborne allergens such as ragweed pollen and provides a unique study environment
      ideally suited to evaluate efficacy and onset of action of various anti-allergic medications.
      This specialized facility, located within Kingston General Hospital, allows for the tight
      regulation of environmental variables such as air quality, temperature, humidity and CO2
      levels as well as the precise maintenance of allergen concentration within this specialized
      room. Thus the EEU provides a closed environment in which participants are exposed to a
      predetermined, controlled, constant level of airborne pollen. All previous studies have used
      either ragweed or grass pollen, and the investigators have not clinically validated the use
      of birch pollen in the EEU. This study will confirm that the birch pollen circulated in the
      EEU can generate allergic rhinitis symptoms similar to those seen in the 'real world', and
      will also provide an opportunity to collect blood from participants before and after allergen
      challenge in order to better understand allergic inflammation, to hopefully someday identify
      novel therapies in allergic disease.

      This study will consist of a Screening Visit and one pollen exposure visit. The duration of
      each participant's participation in the study from Screening to End of Study (EOS) will be
      approximately 3 weeks. The study population will consist of healthy, ambulatory male and
      female volunteers, 18-65 years of age with either a history of seasonal allergic rhinitis or
      a history of no allergic reactions. Approximately 55-75 participants will be screened to
      ensure 50 eligible participants are enrolled into the study (40 allergic, 10 non-allergic).

      All participants will give written informed consent prior to any study procedures being
      performed. Participants who meet all inclusion/exclusion criteria during the screening
      process will be asked to return to the EEU for their pollen exposure visit. At the Screening
      visit participants will provide a full medical history and undergo a physical examination.
      They will have their height/weight and vitals measured and skin testing will be performed to
      confirm allergic response to a panel of common aeroallergens (or lack of response for the
      non-allergic individuals). Women of child bearing potential will undergo a urine pregnancy
      test to rule out pregnancy. Eligible participants will be asked to return to the research
      site for one 4 hour exposure to birch pollen in the Environmental Exposure Unit (EEU).
      Peripheral blood samples will be collected before and after pollen exposure for measurement
      of potential biomarkers.
    

Intervention name(s): Birch Pollen; Nasal Brushing
Intervention type(s): Other; Procedure
Intervention description(s): Participants will be exposed to birch pollen to activate their allergy symptoms therefore validating the unit.; 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.