Systemic Mechanisms in Allergic Rhinitis: Assessment of Metabolomic Outcomes.
NMR
1 other identifier
observational
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFirst Posted
Study publicly available on registry
September 3, 2014
CompletedApril 21, 2015
April 1, 2015
1 month
August 15, 2014
April 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
IgE testing
Participant visits from July 2014 - September 2014; samples and data will be analyzed and presented for up to 2 years following participant visits.
Epigenetics
Participant visits from July 2014 - September 2014; samples and data will be analyzed and presented for up to 2 years following participant visits.
Eligibility Criteria
Healthy males and females 18-55 years old with ragweed induced allergic rhinitis.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kingston General Hospital
Kingston, Ontario, K7L2V6, Canada
Related Links
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne K Ellis, MD MSc FRCPC
Queen's University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Anne K. Ellis MD MSc FRCPC
Study Record Dates
First Submitted
August 15, 2014
First Posted
September 3, 2014
Study Start
August 1, 2014
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
April 21, 2015
Record last verified: 2015-04