AllerGen investigator Dr. Anne Ellis (Queen’s University) and her team have produced a clinically validated protocol for conducting nasal allergen challenges (NACs) in clinical trials.
The optimized protocol, and its application in a unique cat allergy study, is described in an April 2018 publication in Clinical and Translational Allergy. The protocol, developed for AllerGen’s Allergic Rhinitis-Clinical Investigator Collaborative (AR-CIC), led by Dr. Ellis, was previously described in a 2015 article in Allergy, Asthma and Clinical Immunology.
The opportunity to validate the protocol arose when British biotech firm Circassia Ltd. approached Dr. Ellis to conduct clinical trials on a vaccine that successfully treats people with an allergy to cats.
The assessment of such novel therapies for allergy can be challenging, requiring large, expensive and time-consuming clinical efficacy trials to achieve statistical power, as the study authors note. However, using the AR-CIC’s optimized NAC protocol, Dr. Ellis’s study was “able to detect significant changes in both subjective and objective measurements of clinical efficacy, in an open label clinical trial … utilizing a population of only 20 allergic subjects.”
This outcome “supports the validity of the AR-CIC’s optimized NAC protocol for conducting research of the potential efficacy of novel therapeutics in multi-centre studies,” the study authors conclude.
Co-authors on the study include AllerGen investigators Dr. Helen Neighbour and Dr. Mark Larché (McMaster), and AllerGen HQP Mena Soliman and Lisa Steacy.
Dr. Ellis is a clinician-scientist recognized for her research into various allergic conditions, especially allergic rhinitis. Her Environmental Exposure Unit (EEU) at Queen’s University is a unique facility capable of conducting a controlled allergen challenge for the study of allergic rhinitis for up to 150 participants at a time.