Tryptase Levels Following Systemic Reactions Associated with Immunotherapy

Abstract

In two randomized double-blind studies, twice-daily GSP301 nasal spray-a fixed-dose combination of olopatadine hydrochloride and mometasone furoate-significantly improved reflective total nasal symptom score (rTNSS) versus placebo (primary endpoint; presented elsewhere). GSP301 onset of action and reflective total ocular symptom scores (rTOSS) are presented here. METHODS: In each study (study 1 [NCT02631551]; study 2 [NCT02870205]), patients > _12 years with seasonal allergic rhinitis (SAR) were equally randomized to GSP301 (olopatadine 665mg/mometasone 25mg BID), olopatadine (665mg BID), mometasone (25mg BID), or placebo for 14 days. GSP301 onset of action was assessed by mean change from baseline in average instantaneous TNSS (iTNSS) at various timepoints (from 15 minutes to 4 hours post-dose) versus placebo and analyzed via mixed-effect model repeated measures, adjusting for covariates. RESULTS: A total of 1,180 and 1,176 patients were randomized in studies 1 and 2, respectively. A rapid onset of action for GSP301 was observed at 15 minutes post-dose versus placebo in study 1 (least squares mean difference [95%