CLINICAL PERFORMANCE AND SAFETY OF AM-301 NASAL SPRAY IN SEASONAL ALLERGIC RHINITIS (NASAR)

This study is a multicenter, open-label, pivotal study to determine the safety and efficacy of treatment with AM-301 in 100 participants who suffer from seasonal allergic rhinitis (AR). AM-301 is a medical device (nasal spray) not yet approved in Australia. It is pharmacologically inactive where its its key ingredient, bentonite, forms a low-permeable barrier in the nostril that prevents contact of allergens with the nasal mucosa. It has shown promise for this mechanism of action in prior research. A saline nasal spray (standard-of-care product) will be used as a comparator. Participants will be screened and then eligible participants will complete a 7-day run-in period to establish their baseline rhinoconjunctivitis quality of life (RQOL), nasal symptoms and outdoor activity through a daily diary. After the run-in period, participants will enter the 2 week treatment period and be randomized to receive AM-301 or saline (no blinding) and will be instructed on how to use them. Participants will self-administer 1 puff of AM-301/saline per nostril 3 times daily or as needed (maximum 8 times per day) and complete RQOL, nasal symptoms and outdoor activity diaries daily for comparison with the run-in period.