Rapid Onset of Action on Nasal Symptoms and Ocular Symptom Relief With Olopatadine/Mometasone Combination Nasal Spray in a Ragweed Environmental Exposure Chamber

RATIONALE: In a randomized, parallel-group, double-blind, proof-of-concept study, GSP301 fixed-dose-combination nasal spray (olopatadine hydrochloride and mometasone furoate) significantly improved instantaneous total nasal symptom scores (iTNSS, primary endpoint) versus placebo in a ragweed pollen Environmental Exposure Chamber (EEC; previously presented). Onset of action and ocular symptom data are presented here.

METHODS: Seasonal allergic rhinitis (SAR) patients (18–65 years; N=180) were equally randomized to GSP301 BID (olopatadine 665μg/mometasone 25μg), GSP301 QD (olopatadine 665μg/mometasone 50μg), Patanase^® (olopatadine 665μg BID), Dymista^® (azelastine 137μg/fluticasone 50μg BID), or placebo (BID) for 14 days. Onset of action was assessed by mean change from baseline in iTNSS from 15 minutes to 4 hours post-dose versus placebo, analyzed via ANCOVA. Instantaneous total ocular symptom scores (iTOSS) and adverse events were assessed.

RESULTS: Onset of action occurred at 10 minutes post-dose for GSP301 BID (least squares mean difference [95% CI]: -1.26 [-2.30, -0.21], P=0.019) and was maintained at later timepoints. Onset of action could not be defined for GSP301 QD, Dymista, or Patanase as statistically significant differences in iTNSS change from baseline between these treatments and placebo were not observed at any 2 consecutive timepoints. Additionally, GSP301 significantly improved iTOSS vs placebo for BID (mean change from baseline to day 14: -1.64 [-2.60, -0.68], P=0.001) and QD dosing (-1.20 [-2.15, -0.24], P=0.015). All treatments were well tolerated.

CONCLUSIONS: In an EEC model, GSP301 BID had a rapid onset of action of 10 minutes and provided significant improvements in ocular symptoms vs placebo. GSP301 QD and BID treatments were well tolerated.