Recruiting

Observational Study

Sponsor:

United Allergy Services

Code:

NCT03514303

Conditions

Allergy Pollen

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Spiriplex Allergenex Microassay

Study Details

Brief 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.

Conditions

Allergy Pollen

Study ID

NCT03514303

Start date

Apr 1, 2018

Status verified date

Jan, 2018

Completion date

Jun, 2019

Anticipated

Primary completion date

Feb, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Ragweed

Subjects will test positive or negative to the allergen Ragweed.

Timothy Grass

Subjects will test positive or negative to the allergen Timothy Grass.

Johnson Grass

Subjects will test positive or negative to the allergen Johnson Grass.

Bermuda Grass

Subjects will test positive or negative to the allergen Bermuda Grass.

Cladosporium

Subjects will test positive or negative to the allergen Cladosporium.

Cat Dander

Subjects will test positive or negative to the allergen Cat Dander.

Cockroach

Subjects will test positive or negative to the allergen Cockroach.

Dust Mite

Subjects will test positive or negative to the allergen Dust Mite.

Oak

Subjects will test positive or negative to the allergen Oak.

Dog Dander

Subjects will test positive or negative to the allergen Dog Dander.

Interventions

Spiriplex Allergenex Microassay

A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.

Primary outcome measure

  • Microassay Tests Completion [ Time Frame: 2-3 months ]

Central Contacts and Locations

Central contacts

William W Wagoner, BS

210-679-3926william.wagoner@unitedallergy.com

Locations

United Allergy Services

Recruiting

San Antonio, Texas, United States, 78216

Contacts

William W Wagoner, BS

210-679-3926william.wagoner@unitedallergy.com

More Information

Sponsor

United Allergy Services

Last update posted

Oct 17, 2018

Last verified

Jan, 2018

Keywords

  • Skin test, Microarray test

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by United Allergy Services on 2018-10-17.