Nasal challenges in allergen immunotherapy trials.

Abstract

The nasal allergen challenge (NAC) model can be a valuable diagnostic tool for allergic rhinitis. Alongside its clinical use, NACs can be used as primary and secondary endpoints in studies evaluating allergen immunotherapy (AIT) products for allergic rhinitis treatment. This review will discuss the technical aspects of the NAC model and provide a summary of recent studies using NACs to assess existing and new AIT treatments. Over the last 2 years, both titrated and single-dose nasal challenge protocols have been used to evaluate immunotherapies targeting grass, birch, house dust mite, and cat allergens. Early efficacy and dose-finding trials showed improvements in allergic symptoms and nasal tolerance to allergens after AIT treatment with standardized extracts or modified forms of whole allergen. NACs were also used in two proof-of-concept studies to illustrate the efficacy of intralymphatic immunotherapy with two concomitant allergens and subcutaneous immunotherapy with Fel d 1-specific IgG-blocking antibodies. Along with existing therapies, nasal challenges are useful in evaluating AIT treatments in the very early stages of clinical development. However, because of the variety in challenge techniques and symptom assessments available, special attention must be placed in the protocol design in order to compare the study results with existing NAC publications.