Clinically Meaningful Improvement in Total Rhinoconjunctivitis Score with Olopatadine/mometasone Combination Nasal Spray in Patients with Seasonal Allergic Rhinitis: A Pooled Analysis

Abstract

The objective of this pooled analysis was to demonstrate the clinically meaningful effect of GSP301, a nasal spray combination of olopatadine hydrochloride (OLO) and mometasone furoate (MF), in treating both nasal and ocular symptoms of seasonal allergic rhinitis (SAR). Results were pooled from 3 double-blind, randomized, placebo-controlled 14-days studies. Patients (12-65 years, n=2,971) with SAR were equally randomized to twice-daily GSP301 (OLO 665 μg/MF 25 μg), OLO (665 μg), MF (25 μg), or placebo. Reflective total of 7 symptom scores (rT7SS, 4 rhinitis + 3 ocular symptoms) were determined. Mean %change from baseline was analyzed using a mixed-effect model repeated measures, 50% responder rates by chi-square tests and time to response by survival analysis. GSP301 effectively reduced rT7SS over the 14 days treatment with relative improvements of 104% and 84% compared to MF (p<0.001) and OLO (p<0.001), respectively. Percent change from baseline in rT7SS was significantly improved with GSP301 (33.58%) compared to placebo (23.28%, p<0.001), OLO (28.90%, p<0.001) and MF (28.20%, p<0.001). Significantly more patients achieved 50% reduction in rT7SS with GSP301 over 14 days with relative improvements of 172% and 116% compared to MF (p<0.001) and OLO (p=0.003). Time to response was significantly faster with GSP301 (30% percentile 4 days) than placebo (10 day, p<0.001), OLO (7 days, p=0.035) and MF (7 days, p=0.017). GSP301 provides a clinically meaningful and statistically significant improvement in total nasal and ocular symptoms compared to individual monotherapies.