Microassay and Allergy Skin Prick Test Correlation 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.

Study Overview

• Status: Unknown
• Conditions: Allergy Pollen
• Intervention / Treatment: Diagnostic test: Spiriplex Allergenex Microassay

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: William W Wagoner, BS; Phone Number: 210-679-3926; Email: william.wagoner@unitedallergy.com

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78216
      • Recruiting
      • United Allergy Services
      • Contact: William W Wagoner, BS; Phone Number: 210-679-3926; Email: william.wagoner@unitedallergy.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Subjects with bleeding disorders or a history of vasovagal reactions to blood draws will not be enrolled in this study.

Study Plan

How is the study designed?

Number of groups / cohorts

10

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ragweed; Subjects will test positive or negative to the allergen Ragweed.	Diagnostic test: Spiriplex Allergenex Microassay; A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.
Timothy Grass; Subjects will test positive or negative to the allergen Timothy Grass.	Diagnostic test: Spiriplex Allergenex Microassay; A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.
Johnson Grass; Subjects will test positive or negative to the allergen Johnson Grass.	Diagnostic test: Spiriplex Allergenex Microassay; A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.
Bermuda Grass; Subjects will test positive or negative to the allergen Bermuda Grass.	Diagnostic test: Spiriplex Allergenex Microassay; A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.
Cladosporium; Subjects will test positive or negative to the allergen Cladosporium.	Diagnostic test: Spiriplex Allergenex Microassay; A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.
Cat Dander; Subjects will test positive or negative to the allergen Cat Dander.	Diagnostic test: Spiriplex Allergenex Microassay; A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.
Cockroach; Subjects will test positive or negative to the allergen Cockroach.	Diagnostic test: Spiriplex Allergenex Microassay; A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.
Dust Mite; Subjects will test positive or negative to the allergen Dust Mite.	Diagnostic test: Spiriplex Allergenex Microassay; A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.
Oak; Subjects will test positive or negative to the allergen Oak.	Diagnostic test: Spiriplex Allergenex Microassay; A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.
Dog Dander; Subjects will test positive or negative to the allergen Dog Dander.	Diagnostic test: Spiriplex Allergenex Microassay; A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2-3 months

Collaborators and Investigators

• Sponsor: United Allergy Services

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: January 25, 2018
• First Submitted That Met QC Criteria: April 30, 2018
• First Posted (Actual): May 2, 2018

Study Record Updates

• Last Update Posted (Actual): October 17, 2018
• Last Update Submitted That Met QC Criteria: October 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Skin test, Microarray test
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Nose Diseases; Rhinitis, Allergic; Rhinitis; Hypersensitivity; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: Microassay study-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No