Efficacy and Safety of Twice-daily and Once-daily Olopatadine-Mometasone Combination Nasal Spray for Seasonal Allergic Rhinitis

Open Access

Charles P. Andrews, MD1,∗,Correspondence information about the author MD Charles P. AndrewsEmail the author MD Charles P. Andrews

, 

Dale Mohar, MD2

, 

Yacine Salhi, PhD3

, 

Sudeesh K. Tantry, PhD3

DOI: https://doi.org/10.1016/j.anai.2019.11.007

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ABSTRACT

BACKGROUND

GSP301 is an investigational fixed-dose combination nasal spray of olopatadine hydrochloride (antihistamine) and mometasone furoate (corticosteroid).

OBJECTIVE

To evaluate efficacy and safety of GSP301 in patients with seasonal AR (SAR).

METHODS

In this phase 2, double-blind, parallel-group study, patients (≥12 years of age) with SAR were equally randomized to twice-daily GSP301 (olopatadine 665μg and mometasone 25μg), once-daily GSP301 (olopatadine 665μg and mometasone 50μg), twice-daily or once-daily olopatadine monotherapy (665μg), mometasone monotherapy (twice-daily 25μg or once-daily 50μg), or placebo for 14 days.

The primary endpoint—mean change from baseline in morning and evening reflective Total Nasal Symptom Score (rTNSS)—was analyzed using ANCOVA (P<0 .05="statistically" 12-hour="" action="" adverse="" also="" and="" assessed.="" average="" evening="" events="" individual="" instantaneous="" itnss="" life="" morning="" ocular="" of="" onset="" p="" quality="" s="" significant="" symptoms="" tnss="" were="">

RESULTS

A total of 1,111 patients were randomized. Twice-daily GSP301 provided statistically significant and clinically meaningful rTNSS improvements versus placebo (P<0 .001="" em="" olopatadine="" twice-daily="">P

=0.049) and mometasone (P=0.004). Similar significant improvements in iTNSS were observed with twice-daily GSP301 versus placebo (P<0 .001="" and="" em="" mometasone="" twice-daily="">P=0.007); improvements were not significant versus olopatadine (P=0.058). Once-daily GSP301 provided significant rTNSS and iTNSS improvements versus placebo and once-daily olopatadine (P<0 .01="" 10.8="" 8.2="" 9.5="" aes="" all="" and="" but="" gsp301="" improvements="" mometasone.="" not="" once-daily="" p="" placebo="" rates="" respectively.="" significant="" treatment-emergent="" twice-daily="" versus="" were="" with="">

CONCLUSION

Twice-daily GSP301 treatment was efficacious and well tolerated, providing statistically significant and clinically meaningful improvements in rTNSS (primary endpoint) versus placebo and both monotherapies.

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