Systemic Mechanisms in Allergic Rhinitis: Assessment of Metabolomic Outcomes.

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.

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kingston General Hospital

Kingston, Ontario, K7L2V6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Official study title

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

Acronym: NMR

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Sep 3, 2014
Registry last updated: Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed