Update on NASAR clinical trial with Bentrio for seasonal allergic rhinitis.

The mean reflective Total Nasal Symptom Score (rTNSS) as the primary efficacy endpoint decreased in the Bentrio group from 6.7 points in the pre-treatment period to 5.1 points over the 14-day treatment period, while the saline spray group showed a decrease from 7.6 to 7.1 points. The treatment effect of 1.55 points in favor of Bentrio was statistically significant in the ANCOVA model (LSmeans; p = 0.015; 95% confidence interval -2.78 to -0.32). The result is well above the minimal clinically important difference of 0.28 points. The interim analysis further showed good tolerability and safety both for Bentrio and the comparator.

For eligibility in the NASAR trial, patients had to rate their rTNSS at 5 points or higher, among meeting other requirements. The TNSS comprises ratings for nasal congestion, sneezing, nasal itching, and rhinorrhea (runny nose) and has a maximum score of 12 points. Participants were randomized at a 1:1 ratio to either receive Bentrio or saline spray via self-administration three times per day, or as needed. Since the interim analysis confirmed the validity of assumptions for the statistical powering of the study, enrollment into the trial was completed at n = 100, as planned. The last patient recently completed its last study visit; the results from the complete trial are expected to become available in Q2 2023.