PMID- 30910440 OWN - NLM STAT- MEDLINE DCOM- 20200106 LR - 20200106 IS - 1534-4436 (Electronic) IS - 1081-1206 (Linking) VI - 122 IP - 6 DP - 2019 Jun TI - Efficacy and safety of olopatadine-mometasone combination nasal spray for the treatment of seasonal allergic rhinitis. PG - 630-638.e3 LID - S1081-1206(19)30196-6 [pii] LID - 10.1016/j.anai.2019.03.017 [doi] AB - BACKGROUND: GSP301 nasal spray is a fixed-dose combination of olopatadine hydrochloride (antihistamine) and mometasone furoate (corticosteroid). OBJECTIVE: To evaluate the efficacy and safety of GSP301 in patients with seasonal allergic rhinitis (SAR). METHODS: In this double-blind study, eligible patients (>/=12 years of age) with SAR were randomized 1:1:1:1 to twice-daily GSP301 (665 mug of olopatadine and 25 mug of mometasone), olopatadine (665 mug), mometasone (25 mug), or placebo for 14 days. The primary end point-mean change from baseline in average morning and evening 12-hour reflective Total Nasal Symptom Score (rTNSS)-was analyzed via a mixed-effect model repeated measures (P < .05 was considered to be statistically significant). Additional assessments included average morning and evening 12-hour instantaneous TNSS (iTNSS), ocular symptoms, individual symptoms, onset of action, quality of life, and adverse events (AEs). RESULTS: A total of 1176 patients were randomized. GSP301 provided statistically significant and clinically meaningful rTNSS improvements vs placebo (least squares mean difference, -1.09; 95% CI, -1.49 to -0.69; P < .001) and vs olopatadine (P = .03) and mometasone (P = .02). Similar significant improvements in iTNSS were also observed with GSP301 (P < .05 for all). Furthermore, GSP301 significantly improved overall ocular symptoms, individual nasal and ocular symptoms, and quality of life vs placebo (P