Olopatadine/Mometasone Combination Nasal Spray Improves Seasonal Allergic Rhinitis Symptoms in an Environmental Exposure Chamber Study

Publication date: Available online 12 October 2018

Source: Annals of Allergy, Asthma & Immunology

Author(s): Piyush Patel, Anne Marie Salapatek, Sudeesh K. Tantry

Abstract

BACKGROUND

GSP301 nasal spray is a fixed-dose combination of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate intended for seasonal allergic rhinitis (SAR) treatment.

OBJECTIVE

Efficacy and safety of GSP301 once-daily (QD) or twice-daily (BID) were evaluated in a ragweed pollen Environmental Exposure Chamber (EEC).

METHODS

In this randomized, double-blind, double-dummy study, adults (18-65 years) with SAR were equally randomized to GSP301 BID (olopatadine 665μg/mometasone 25μg), GSP301 QD (olopatadine 665μg/mometasone 50μg), AzeFlu (FDA-approved azelastine 137μg/fluticasone 50μg BID), Olopatadine (FDA-approved formulation 665μg BID), or placebo (BID). During two visits (baseline and end of 14-day treatment), participants assessed SAR symptoms at specified time points. The primary endpoint—mean change from baseline in instantaneous Total Nasal Symptom Score (iTNSS) for GSP301 BID or QD versus placebo—was analyzed by ANCOVA. Onset of action, ocular symptoms, and adverse events (AEs) were assessed.

RESULTS

A total of 180 participants were randomized. Treatment with GSP301 BID or QD provided statistically significant improvements in Itnss versus placebo (least squares mean difference [95% CI] GSP301 BID: -3.60 [-4.89, -2.30]; QD: -3.05 [-4.35, -1.76]; P<0.0001, both). Significant improvements in iTNSS with GSP301 BID occurred by 10 minutes post-dose (- 1.26 [-2.30, -0.21], P=0.019) and were maintained at all later time points except one (2.5 hours). Treatment-emergent AEs occurred in 22.2%, 30.6%, 25.0%, 22.2%, and 16.7% of participants in GSP301 BID, GSP301 QD, AzeFlu, Olopatadine, and placebo groups, respectively.

CONCLUSION

In an EEC model, GSP301 BID and QD treatments were well tolerated and provided statistically significant and clinically meaningful SAR symptom improvement versus placebo.

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