The following is a summary of “AM-301, a barrier-forming nasal spray, versus saline spray in seasonal allergic rhinitis: A randomized clinical trial,” published in the April 2024 issue of Allergy & Immunology by Becker, et al.

Saline nasal sprays are commonly used to manage seasonal allergic rhinitis (SAR) by cleansing the nasal cavity and clearing aeroallergens. In contrast, AM-301 nasal spray employs a drug-free mechanism by forming a thin film barrier on the nasal mucosa. This barrier prevents allergen contact, traps allergens, and facilitates their elimination. For a study, researchers sought to compare the efficacy, safety, and tolerability of AM-301 versus saline nasal spray for the treatment of SAR.

In the randomized clinical trial, 100 patients with SAR were assigned in a 1:1 ratio to receive either AM-301 or saline nasal spray three times daily for 2 weeks. The primary efficacy endpoint was the reduction in the mean daily reflective Total Nasal Symptom Score (rTNSS). Secondary efficacy endpoints included the reduction in the mean instantaneous TNSS, improvements in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), and the global impression of efficacy. Safety and tolerability were evaluated by monitoring adverse events, the use of relief medication, the number of symptom-free days, and the global impression of tolerability.

Patients treated with AM-301 demonstrated a significantly more significant reduction in rTNSS compared to those using saline, with a least squares mean difference of −1.1 (95% CI: −1.959 to −0.241, P = 0.013), indicating superior improvement in overall nasal symptoms. All secondary efficacy endpoints also favored AM-301, significantly improving the overall RQLQ score (P < 0.001) for each RQLQ domain. Additionally, AM-301 was associated with fewer patients requiring relief medication and more patients experiencing symptom-free days compared to the saline group. Both AM-301 and saline treatments exhibited similar safety and tolerability profiles.

AM-301 was found to be more effective than saline nasal spray in reducing nasal symptoms and improving the quality of life for patients with seasonal allergic rhinitis. Despite similar safety and tolerability between the two treatments, AM-301 demonstrated notable benefits through its barrier approach, offering a promising alternative for SAR management.

Reference: onlinelibrary.wiley.com/doi/10.1111/all.16116