Olopatadine plus mometasone for seasonal allergic rhinitis treatment: A pooled analysis of clinical trials

Nakanishi M, Carbone LFB, Aggarwal V t al. Braz J Otorhinolaryngol. 2026 Apr 14;92(4):101817. doi: 10.1016/j.bjorl.2026.101817. 

Highlights

• First pooled analysis of Olopatadine/Mometasone FDC.

• Reinforces significant improvements compared to mometasone and olopatadine.

• Compiled safety data demonstrate low AEs and high adherence to treatment.

Abstract

Objective

This study was conducted to analyze the efficacy and safety of a fixed-dose combination of olopatadine HCl (antihistamine) and mometasone furoate (corticosteroid) (Olo/Mom, GSP301) for the treatment of Seasonal Allergic Rhinitis (SAR).

Methods

Efficacy data from one phase II (NCT02318303 [GSP301-201]) and two pivotal phase III double-blind, randomized, active, placebo-controlled (NCT02631551 [GSP301-301] and NCT02870205 [GSP301-304]) clinical trials were collated and analyzed. These studies investigated Olo/Mom (administered twice daily/BID) compared with placebo and its monotherapy constituents for the treatment of SAR in patients aged ≥12-years.

In addition, safety data were analyzed from the aforementioned studies and a proof-of-concept study (NCT03444506 [GSP301-POC]). Primary and secondary endpoints were compared between Olo/Mom, its active mometasone and olopatadine constituents, and placebo.

Results

(A) Differences in mean score change from baseline to day 14,
LS means with 95% CIs of average a.m. and p.m. rTNSS
(individual studies and all pooled participants, full analysis set).
(B) LS means of change in average a.m. and p.m.
rTNSS for each day (all pooled participants, full analysis set). 

For the efficacy analyses (n = 2971), Olo/Mom significantly reduced rTNSS scores compared with placebo (Least Square Mean Difference [LSMD = −0.94]; 95% CI: −1.17, −0.70; p < 0.0001), olopatadine (LSMD = −0.37; 95% CI: −0.60, −0.14; p = 0.0019), and mometasone (LSMD = −0.42; 95% CI: −0.65, −0.18; p = 0.0005). Olo/Mom also significantly improved the RQLQ and iTNSS scores compared with placebo and its monotherapy constituents (p < 0.05, all). The onset of action of Olo/Mom was observed at 15-minutes and was sustained at subsequent timepoints. The incidence of treatment-emergent adverse events in the Olo/Mom, placebo, olopatadine, and mometasone groups was 13.9%, 9.5%, 13.2%, and 7.9%, respectively.

Conclusion

This pooled analysis demonstrated the superiority of Olo/Mom compared to its monotherapy constituents or placebo in reducing SAR symptoms over 14-days. Moreover, this study showed that Olo/Mom has a rapid onset of action and significantly improves RQLQ scores compared to placebo. Administration of Olo/Mom BID is an effective and well-tolerated option for the treatment of SAR in patients aged 12-years or older.

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