<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02230475</url>
  </required_header>
  <id_info>
    <org_study_id>Kingston General Hospital</org_study_id>
    <nct_id>NCT02230475</nct_id>
  </id_info>
  <brief_title>Systemic Mechanisms in Allergic Rhinitis: Assessment of Metabolomic Outcomes.</brief_title>
  <acronym>NMR</acronym>
  <official_title>Systemic Mechanisms in Allergic Rhinitis: Assessment of Metabolomic Outcomes Using the Environmental Exposure Unit (EEU). Part 2.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen's University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Queen's University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical study will use the Environmental Exposure Unit (EEU) to generate allergic&#xD;
      rhinitis symptoms in participants under controlled conditions, to collect well-characterized&#xD;
      biological samples (urine and blood) before and after they develop these symptoms. The EEU&#xD;
      provides the ability to control the timing, duration and levels of allergen exposure, and&#xD;
      also other outside environmental factors, yielding ideal biologic samples for analysis with&#xD;
      novel, cutting-edge molecular techniques. Results from the analysis of these unique allergic&#xD;
      rhinitis samples should help determine if the technique of urine Nuclear Magnetic Resonance&#xD;
      analysis could be a useful diagnostic tool in allergic rhinitis. IgE testing will be done on&#xD;
      blood samples and compared to spin prick testing and symptoms of allergic rhinitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>Metabolomics</measure>
    <time_frame>Participant visits from July 2014 - September 2014; samples and data will be analyzed and presented for up to 2 years following participant visits.</time_frame>
    <description>Determine if urine NMR metabolic profiles from participants with allergic rhinitis will be significantly different from that of healthy participants (healthy controls were included in part 1 of the 2010 study) and if changes in urine NMR profile correlate with disease severity. NMR will be reported</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>IgE testing</measure>
    <time_frame>Participant visits from July 2014 - September 2014; samples and data will be analyzed and presented for up to 2 years following participant visits.</time_frame>
    <description>Blood samples will be collected from participants to measure ragweed specific IgE levels and compare them to their individual skin testing wheal size as well as their symptoms of allergic rhinitis in the EEU before and after pollen exposure. These symptoms are reported on a questionnaire completed by the participant every 20 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epigenetics</measure>
    <time_frame>Participant visits from July 2014 - September 2014; samples and data will be analyzed and presented for up to 2 years following participant visits.</time_frame>
    <description>Blood samples will be collected to examine epigenetic biomarkers in relation to symptoms of allergic rhinitis before and after exposure in the EEU. These symptoms are reported on a questionnaire completed by the participant every 20 minutes.</description>
  </secondary_outcome>
  <enrollment type="Actual">15</enrollment>
  <condition>Allergic Rhinitis</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urine samples will be retained for analysis via nuclear magnetic resonance. Blood samples&#xD;
      will be retained after separating the mononuclear layer. These samples will be tested for&#xD;
      epigenetic changes. Blood samples will also be retained for IgE testing.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy males and females 18-55 years old with ragweed induced allergic rhinitis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is a healthy, ambulatory male or female volunteer 18 to 55 years of age.&#xD;
&#xD;
          -  Participant has a history of Seasonal Allergic Rhinitis due to ragweed for the last&#xD;
             two consecutive ragweed seasons.&#xD;
&#xD;
          -  Participant has a positive response (wheal diameter greater than or equal to 3 mm&#xD;
             larger than diluent control) to a skin prick test to short ragweed allergen at&#xD;
             screening or within 12 months of screening visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant is a female that is pregnant, lactating or actively trying to become&#xD;
             pregnant.&#xD;
&#xD;
          -  smokers&#xD;
&#xD;
          -  Participant is unable to comply with the washout periods for prohibited medications.&#xD;
&#xD;
          -  Participant is currently receiving allergen specific immunotherapy injections.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne K Ellis, MD MSc FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen's University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kingston General Hospital</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L2V6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://eeu.on.ca</url>
    <description>Related Info</description>
  </link>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>April 20, 2015</last_update_submitted>
  <last_update_submitted_qc>April 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Queen's University</investigator_affiliation>
    <investigator_full_name>Dr. Anne Ellis</investigator_full_name>
    <investigator_title>Dr. Anne K. Ellis MD MSc FRCPC</investigator_title>
  </responsible_party>
  <keyword>Allergic Rhinitis</keyword>
  <keyword>NMR</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis</mesh_term>
    <mesh_term>Rhinitis, Allergic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02230475
org study id: Kingston General Hospital
nct id: NCT02230475
lead sponsor: 
has dmc: No
This clinical study will use the Environmental Exposure Unit (EEU) to generate allergic
      rhinitis symptoms in participants under controlled conditions, to collect well-characterized
      biological samples (urine and blood) before and after they develop these symptoms. The EEU
      provides the ability to control the timing, duration and levels of allergen exposure, and
      also other outside environmental factors, yielding ideal biologic samples for analysis with
      novel, cutting-edge molecular techniques. Results from the analysis of these unique allergic
      rhinitis samples should help determine if the technique of urine Nuclear Magnetic Resonance
      analysis could be a useful diagnostic tool in allergic rhinitis. IgE testing will be done on
      blood samples and compared to spin prick testing and symptoms of allergic rhinitis.
observational model: Cohort
measure: Metabolomics
time frame: Participant visits from July 2014 - September 2014; samples and data will be analyzed and presented for up to 2 years following participant visits.
description: Determine if urine NMR metabolic profiles from participants with allergic rhinitis will be significantly different from that of healthy participants (healthy controls were included in part 1 of the 2010 study) and if changes in urine NMR profile correlate with disease severity. NMR will be reported
measure: IgE testing
time frame: Participant visits from July 2014 - September 2014; samples and data will be analyzed and presented for up to 2 years following participant visits.
description: Blood samples will be collected from participants to measure ragweed specific IgE levels and compare them to their individual skin testing wheal size as well as their symptoms of allergic rhinitis in the EEU before and after pollen exposure. These symptoms are reported on a questionnaire completed by the participant every 20 minutes.
measure: Epigenetics
time frame: Participant visits from July 2014 - September 2014; samples and data will be analyzed and presented for up to 2 years following participant visits.
description: Blood samples will be collected to examine epigenetic biomarkers in relation to symptoms of allergic rhinitis before and after exposure in the EEU. These symptoms are reported on a questionnaire completed by the participant every 20 minutes.
Urine samples will be retained for analysis via nuclear magnetic resonance. Blood samples
      will be retained after separating the mononuclear layer. These samples will be tested for
      epigenetic changes. Blood samples will also be retained for IgE testing.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Anne K Ellis, MD MSc FRCPC
role: Principal Investigator
affiliation: Queen's University
facility: 
country: Canada
url: http://eeu.on.ca
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Queen's University
investigator full name: Dr. Anne Ellis
investigator title: Dr. Anne K. Ellis MD MSc FRCPC
mesh term: Rhinitis
mesh term: Rhinitis, Allergic