Microassay and Allergy Skin Prick Test Correlation Study

Allergy Pollen Clinical Trial

Official title:

Microassay and Allergy Skin Prick Test Correlation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03514303
• Other study ID #: Microassay study-1
• Status: Recruiting
• Start date: April 1, 2018
• Est. completion date: June 2019

Study information

• Verified date: January 2018
• Source: United Allergy Services
• Contact: William W Wagoner, BS
• Phone: 210-679-3926
• Email: william.wagoner[@]unitedallergy.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allergy Pollen
• Hypersensitivity
• Rhinitis, Allergic, Seasonal

Intervention

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.

Locations

Country	Name	City	State
United States	United Allergy Services	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
United Allergy Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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