546:
Efficacy and Safety of Olopatadine/Mometasone Combination Nasal Spray in Patients With Seasonal Allergic Rhinitis
Sunday, March 4, 2018
South Hall A2 (Convention Center)
Frank C. Hampel, MD, Andrew J. Pedinoff, MD, Robert L. Jacobs, MD, Aurora Breazna, PhD, Cynthia F. Caracta, MD, Sudeesh K. Tantry, PhD
RATIONALE: Combining an intranasal antihistamine with an intranasal corticosteroid for the treatment of allergic rhinitis (AR) may provide improved symptom relief over monotherapy treatment. GSP301 nasal spray is a fixed-dose combination of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate. The efficacy and safety of GSP301 were evaluated in a large, phase 3 seasonal AR (SAR) study.

METHODS: In this double-blind, randomized, parallel-group study [NCT02631551], patients (≥12 years) with SAR were equally randomized to twice-daily GSP301 (olopatadine 665μg/mometasone 25μg BID), olopatadine HCl (665μg BID), mometasone furoate (25μg BID), or placebo (BID) for 14 days. The primary efficacy endpoint was the mean change from baseline in AM and PM reflective total nasal symptom scores (rTNSS), analyzed using mixed-effect model repeated measures. Adverse events (AEs) were also assessed.

RESULTS: A total of 1,180 patients were randomized. GSP301 significantly improved rTNSS versus placebo (least squares mean difference [95% CI]: -0.98 [-1.38, -0.57], P<0.001) and versus olopatadine (-0.61 [-1.01, -0.21]; P=0.003). A clinically meaningful, numerical improvement in rTNSS that approached significance was observed with GSP301 versus mometasone (-0.39 [-0.79, 0.01], P=0.059). Compared with placebo, mometasone monotherapy significantly improved rTNSS (‑0.59 [‑1.00, -0.19]; P=0.004), but olopatadine monotherapy was not significant (‑0.37 [‑0.78, 0.04]; P=0.076). Additionally, the percentages of patients with treatment-emergent AEs were similar across treatment groups: 12.9%, 12.5%, 7.1% and 9.4% in the GSP301, olopatadine, mometasone, and placebo groups, respectively.

CONCLUSIONS: In this study, twice-daily GSP301 treatment provided significant and clinically meaningful improvements in SAR nasal symptoms versus placebo and was well tolerated.