Allergic RhinitisNMRNCT02230475
Systemic Mechanisms in Allergic Rhinitis: Assessment of Metabolomic Outcomes.
An observational study of Allergic Rhinitis, run by Queen's University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergic Rhinitis
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Healthy males and females 18-55 years old with ragweed induced allergic rhinitis.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systemic Mechanisms in Allergic Rhinitis: Assessment of Metabolomic Outcomes Using the Environmental Exposure Unit (EEU). Part 2.
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.
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic Rhinitis, NMR
- Medical subject headings
- Rhinitis, Allergic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 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.
Measured: Participant visits from July 2014 - September 2014; samples and data will be analyzed and presented for up to 2 years following participant visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Anne Ellis, Queen's University
- Investigators
- Anne K Ellis, MD MSc FRCPC, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230475
- Sponsor's protocol ID
- Kingston General Hospital
- Acronym
- NMR
- Status last verified
- Apr 2015
- First submitted
- 15 Aug 2014
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Mechanisms in Allergic Rhinitis: Assessment of Metabolomic Outcomes Using the Environmental Exposure Unit (EEU). Part 2.
- ClinicalTrials.gov ID
- NCT02230475
- Acronym / sponsor ID
- NMR / Kingston General Hospital
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic Rhinitis, NMR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Healthy males and females 18-55 years old with ragweed induced allergic rhinitis.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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
2 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne K Ellis, MD MSc FRCPC principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2015.