Systemic Mechanisms in Allergic Rhinitis: Assessment of Metabolomic Outcomes.

NCT ID: NCT02230475

Last Updated: 2015-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2014-09-30

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.

Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Observational Model Type

COHORT

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen's University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Anne Ellis

Dr. Anne K. Ellis MD MSc FRCPC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne K Ellis, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

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Kingston General Hospital

Kingston, Ontario, Canada

Site Status

Countries

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Canada

Related Links

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http://eeu.on.ca

Related Info

Other Identifiers

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Kingston General Hospital

Identifier Type: -

Identifier Source: org_study_id

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