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Effect of HSA or Saline Diluent on Immunotherapy Extract Stability as Determined by Graded ID Skin Tests

Allergic Rhinitis Clinical Trial

Official title:
Effect of HSA or Saline Diluent on Immunotherapy Extract Stability as Determined by Graded ID Skin Tests

Clinical Trial Summary

This is a double-blind study with respect to the diluents used, with patients known to be allergic to the specific allergen tested. Three study sites will be involved, each testing one allergen (Cat, Mite, Timothy grass pollen). Subjects who are known to be allergic to the allergen in question will be tested with serial three-fold dilutions to determine the ID 50 and relative extract potency using the method described by Turkeltaub.

Clinical Trial Description

The specific objective of this study is to determine the stability of immunotherapy extract dilutions. Higher dilutions (lower potency) have been shown in vitro to decrease in potency over time more rapidly than less dilute preparations. The investigators hope to determine whether there is a detectable difference in skin test reaction of dilutions of three common antigens (Cat, Timothy Grass, Dust Mite). The diluents used strongly affect the strength when extract potency is tested in vitro. Therefore, the investigators expect to find a detectable difference in skin test potency based on the diluents used (Saline vs. HSA Saline [300mcg/ml]). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01989897
Study type Interventional
Source Ohio State University
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date March 2013
Completion date November 2015
View Details
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