Allergy Pollen Clinical Trial
Official title:
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.
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.
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