Clinical Trial: Systemic Mechanisms in Allergic Rhinitis: Assessment of Metabolomic Outcomes.

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Systemic Mechanisms in Allergic Rhinitis: Assessment of Metabolomic Outcomes Using the Environmental Exposure Unit (EEU). Part 2.

Brief Summary: 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.

Detailed Summary:
Sponsor: Queen's University

Current Primary Outcome: 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. ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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. ]
    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.
  • 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. ]
    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.


Original Secondary Outcome: Same as current

Information By: Queen's University

Dates:
Date Received: August 15, 2014
Date Started: August 2014
Date Completion:
Last Updated: April 20, 2015
Last Verified: April 2015