Allergy PollenNCT03514303
Microassay and Allergy Skin Prick Test Correlation Study
An observational study of Allergy Pollen, run by United Allergy Services at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the potential correlation of the results of allergen-specific skin prick tests (SPT) to that of allergen-specific microarray determination (microassay test). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergy Pollen
- What is being tested?
- Spiriplex Allergenex Microassay
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to Jun 2019
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects 18 years of age or over who have never initiated a course of allergy immunotherapy or have not completed more than three months of subcutaneous immunotherapy will be enrolled. They will have performed an allergen specific skin prick test within the last 2 years through United Allergy Services.
Who may be able to join
- Subjects 18 years of age or over who have never initiated a course of allergy immunotherapy or have not completed more than three months of subcutaneous immunotherapy will be enrolled.
Who cannot join
- Subjects with bleeding disorders or a history of vasovagal reactions to blood draws will not be enrolled in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
United Allergy Services
San Antonio, Texas, 78216
William W Wagoner, BS, 210-679-3926, william.wagoner@unitedallergy.com
About this study
The purpose of this study is to evaluate the potential correlation of the results of allergen-specific skin prick tests (SPT) to that of allergen-specific microarray determination (microassay test). Subjects who meet enrollment criteria, after signing an IRB approved consent form, will perform a minor finger prick blood draw and blot to be mailed off for microassay analysis. Specific statistical analysis will be done to assess all potential correlations between SPT and microassay. This study design should enable assessment of the level of correlation between SPT results and microassay results for specified allergens within a cohort of subjects with allergic rhinitis.
Read the detailed description
Prospective subjects for study entry will initially be screened by the results of their allergy skin test that were acquired within the past two years. In order to be a prospective subject positive SPT results of five of the following ten allergens will be required: Dust Mite, Ragweed, Cat Dander, Johnson Grass, Bermuda Grass, Timothy Grass, Oak, Cladosporium, Dog Dander, and Cockroach. After signing an IRB approved consent form, these patients will undergo a finger prick blood draw and blot. This study will be conducted in compliance with the protocol, GCP and applicable regulatory requirements.
Subjects 18 years of age or over who have never initiated a course of allergy immunotherapy or have not completed more than three months of SCIT immunotherapy will be enrolled.
Sub-investigator(s) will screen patient charts from a database of patients previously tested using the UAS protocol. Patients that qualify based on inclusion criteria will be contacted by phone and asked if they would be willing to participate in this study.
Subject arrives to the clinic and all inclusion and exclusion criteria are verified by their primary physician and the sub-investigator. Sub-investigator insures that the IRB verified consent form is signed and that the patient has no questions. Subject or sub-investigator will perform the finger prick and blot using the instructions listed on the Allergenex sample collection packet. The sample will be mailed to Spiriplex to be analyzed using their microarray device. The microassay results will be sent to the primary investigation site for correlation analysis with the previously logged SPT results. These results will be blinded to the statisticians and researchers that will be determining potential correlation between SPT and microassay results.
- Conditions
- Allergy Pollen
- Being tested
- Spiriplex Allergenex Microassay
- Keywords
- Skin test, Microarray test
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spiriplex Allergenex MicroassayDiagnostic test
A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.
| Study group | Role | What they receive |
|---|---|---|
| Ragweed | Subjects will test positive or negative to the allergen Ragweed. Receives: Diagnostic Test: Spiriplex Allergenex Microassay | |
| Timothy Grass | Subjects will test positive or negative to the allergen Timothy Grass. Receives: Diagnostic Test: Spiriplex Allergenex Microassay | |
| Johnson Grass | Subjects will test positive or negative to the allergen Johnson Grass. Receives: Diagnostic Test: Spiriplex Allergenex Microassay | |
| Bermuda Grass | Subjects will test positive or negative to the allergen Bermuda Grass. Receives: Diagnostic Test: Spiriplex Allergenex Microassay | |
| Cladosporium | Subjects will test positive or negative to the allergen Cladosporium. Receives: Diagnostic Test: Spiriplex Allergenex Microassay | |
| Cat Dander | Subjects will test positive or negative to the allergen Cat Dander. Receives: Diagnostic Test: Spiriplex Allergenex Microassay | |
| Cockroach | Subjects will test positive or negative to the allergen Cockroach. Receives: Diagnostic Test: Spiriplex Allergenex Microassay | |
| Dust Mite | Subjects will test positive or negative to the allergen Dust Mite. Receives: Diagnostic Test: Spiriplex Allergenex Microassay | |
| Oak | Subjects will test positive or negative to the allergen Oak. Receives: Diagnostic Test: Spiriplex Allergenex Microassay | |
| Dog Dander | Subjects will test positive or negative to the allergen Dog Dander. Receives: Diagnostic Test: Spiriplex Allergenex Microassay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microassay Tests Completion
All patients will be tested by microassay for the 10 allergen groups for comparison to historic skin prick tests of the same 10 allergens.
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start1 Apr 2018
- Primary completionFeb 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy PollenStudies 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
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- United Allergy Services
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514303
- Sponsor's protocol ID
- Microassay study-1
- Status last verified
- Jan 2018
- First submitted
- 25 Jan 2018
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microassay and Allergy Skin Prick Test Correlation Study
- ClinicalTrials.gov ID
- NCT03514303
- Acronym / sponsor ID
- Microassay study-1
- Conditions
- Allergy Pollen
- Keywords
- Skin test, Microarray test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- United Allergy ServicesIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 2 May 2018 (actual)
- 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.
The purpose of this study is to evaluate the potential correlation of the results of allergen-specific skin prick tests (SPT) to that of allergen-specific microarray determination (microassay test). Subjects who meet enrollment criteria, after signing an IRB approved consent form, will perform a minor finger prick blood draw and blot to be mailed off for microassay analysis. Specific statistical analysis will be done to assess all potential correlations between SPT and microassay. This study design should enable assessment of the level of correlation between SPT results and microassay results for specified allergens within a cohort of subjects with allergic rhinitis.
Detailed description
Prospective subjects for study entry will initially be screened by the results of their allergy skin test that were acquired within the past two years. In order to be a prospective subject positive SPT results of five of the following ten allergens will be required: Dust Mite, Ragweed, Cat Dander, Johnson Grass, Bermuda Grass, Timothy Grass, Oak, Cladosporium, Dog Dander, and Cockroach. After signing an IRB approved consent form, these patients will undergo a finger prick blood draw and blot. This study will be conducted in compliance with the protocol, GCP and applicable regulatory requirements.
Subjects 18 years of age or over who have never initiated a course of allergy immunotherapy or have not completed more than three months of SCIT immunotherapy will be enrolled.
Sub-investigator(s) will screen patient charts from a database of patients previously tested using the UAS protocol. Patients that qualify based on inclusion criteria will be contacted by phone and asked if they would be willing to participate in this study.
Subject arrives to the clinic and all inclusion and exclusion criteria are verified by their primary physician and the sub-investigator. Sub-investigator insures that the IRB verified consent form is signed and that the patient has no questions. Subject or sub-investigator will perform the finger prick and blot using the instructions listed on the Allergenex sample collection packet. The sample will be mailed to Spiriplex to be analyzed using their microarray device. The microassay results will be sent to the primary investigation site for correlation analysis with the previously logged SPT results. These results will be blinded to the statisticians and researchers that will be determining potential correlation between SPT and microassay results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Ragweed | – | Diagnostic Test: Spiriplex Allergenex MicroassaySubjects will test positive or negative to the allergen Ragweed. |
| Timothy Grass | – | Diagnostic Test: Spiriplex Allergenex MicroassaySubjects will test positive or negative to the allergen Timothy Grass. |
| Johnson Grass | – | Diagnostic Test: Spiriplex Allergenex MicroassaySubjects will test positive or negative to the allergen Johnson Grass. |
| Bermuda Grass | – | Diagnostic Test: Spiriplex Allergenex MicroassaySubjects will test positive or negative to the allergen Bermuda Grass. |
| Cladosporium | – | Diagnostic Test: Spiriplex Allergenex MicroassaySubjects will test positive or negative to the allergen Cladosporium. |
| Cat Dander | – | Diagnostic Test: Spiriplex Allergenex MicroassaySubjects will test positive or negative to the allergen Cat Dander. |
| Cockroach | – | Diagnostic Test: Spiriplex Allergenex MicroassaySubjects will test positive or negative to the allergen Cockroach. |
| Dust Mite | – | Diagnostic Test: Spiriplex Allergenex MicroassaySubjects will test positive or negative to the allergen Dust Mite. |
| Oak | – | Diagnostic Test: Spiriplex Allergenex MicroassaySubjects will test positive or negative to the allergen Oak. |
| Dog Dander | – | Diagnostic Test: Spiriplex Allergenex MicroassaySubjects will test positive or negative to the allergen Dog Dander. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects 18 years of age or over who have never initiated a course of allergy immunotherapy or have not completed more than three months of subcutaneous immunotherapy will be enrolled. They will have performed an allergen specific skin prick test within the last 2 years through United Allergy Services.
Key inclusion criteria (1 listed)
- Subjects 18 years of age or over who have never initiated a course of allergy immunotherapy or have not completed more than three months of subcutaneous immunotherapy will be enrolled.
Key exclusion criteria (1 listed)
- Subjects with bleeding disorders or a history of vasovagal reactions to blood draws will not be enrolled in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spiriplex Allergenex MicroassayA microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins. | Diagnostic test | Bermuda Grass, Cat Dander, Cladosporium, Cockroach, Dog Dander, Dust Mite, Johnson Grass, Oak, Ragweed, Timothy Grass |
Primary outcome
Microassay Tests Completion
Time frame: 2-3 months
All patients will be tested by microassay for the 10 allergen groups for comparison to historic skin prick tests of the same 10 allergens.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Individual participant dataSharing planned: No
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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.
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 Allergy Pollen, run by United Allergy Services at 1 site in United States.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Oct 2018. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact William W Wagoner, BS (210-679-3926, william.wagoner@unitedallergy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microassay Tests Completion (time frame: 2-3 months). 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 17 Oct 2018.