Systemic Mechanisms in Allergic Rhinitis: Assessment of Metabolomic Outcomes.

Study Overview
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Brief Summary
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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.

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

Conditions
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Allergic Rhinitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is a healthy, ambulatory male or female volunteer 18 to 55 years of age. Participant has a history of Seasonal Allergic Rhinitis due to ragweed for the last two consecutive ragweed seasons. Participant has a positive response (wheal diameter greater than or equal to 3 mm larger than diluent control) to a skin prick test to short ragweed allergen at screening or within 12 months of screening visit. Exclusion Criteria: Participant is a female that is pregnant, lactating or actively trying to become pregnant. smokers Participant is unable to comply with the washout periods for prohibited medications. Participant is currently receiving allergen specific immunotherapy injections.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolomics | 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 | Participant visits from July 2014 - September 2014; samples and data will be analyzed and presented for up to 2 years following participant visits. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IgE testing | 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. | Participant visits from July 2014 - September 2014; samples and data will be analyzed and presented for up to 2 years following participant visits. | 
| Epigenetics | 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. | Participant visits from July 2014 - September 2014; samples and data will be analyzed and presented for up to 2 years following participant visits. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NMR, Allergic Rhinitis