OLOPATADINE/MOMETASONE COMBINATION NASAL SPRAY EFFECTIVELY IMPROVES SEASONAL ALLERGIC RHINITIS NASAL SYMPTOMS AND QUALITY OF LIFE

Introduction Seasonal allergic rhinitis (SAR) symptoms are troublesome and may contribute to impaired quality of life (QoL). In a randomized, double-blind phase 2 study, fixed-dose combination of once-daily (QD) or twice-daily (BID) olopatadine hydrochloride/mometasone furoate nasal spray (GSP301) significantly improved average AM and PM reflective Total Nasal Symptom Scores (rTNSS; primary endpoint, presented elsewhere) vs placebo. Additional efficacy and QoL endpoints are reported here. Methods Patients with SAR (≥12 years; N=1,111) were equally randomized to GSP301 BID (olopatadine 665μg/mometasone 25μg), GSP301 QD (olopatadine 665μg/mometasone 50μg), olopatadine (665μg BID/QD), mometasone (25μg BID or 50μg QD), or placebo for 14 days. Mean change from baseline in average 12-hour AM and PM instantaneous TNSS (iTNSS), Physician-assessed Nasal Symptom Score (PNSS), and Rhinoconjunctivitis Quality of Life Questionnaire–Standardized Activities [RQLQ(S)] for GSP301 BID and QD vs placebo were analyzed using analysis of covariance (ANCOVA; P Results Compared with placebo, GSP301 BID and QD significantly improved iTNSS (least squares mean difference [97.5% CI] GSP301 BID: -1.11 [-1.65, -0.57]; QD: -1.11 [-1.64, -0.57]; PPPPP=0.005) vs placebo. Treatment-emergent AEs were 10.8%, 9.5%, and 8.2%, for GSP301 BID, QD, and placebo groups, respectively. Conclusions GSP301 BID and QD treatments provided statistically significant improvements in both SAR nasal symptoms and QoL vs placebo.