Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR)

Phase 3 Completed 1176 enrolled Glenmark Specialty S.A.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Study to evaluate the efficacy, safety and tolerability of GSP 301 NS compared with placebo NS and individual monotherapy formulations for the treatment of Seasonal Allergic Rhinitis (subjects 12 years of age and older)

Timeline

Start: 2016-08
Primary completion: 2017-01
Completion: 2017-01

Outcome

Met primary endpoint

paper GSP301 provided statistically significant and clinically meaningful rTNSS improvements vs placebo (least squares mean difference, -1.09; 95% CI, -1.49 to -0.69; P < .001) PMID 30910440 ↗

registry analysis (superiority test); GSP 301 Placebo NS vs GSP 301 NS; p <0.001; ANCOVA NCT02870205 ↗

Publications

Gross GN, Berman G, Amar NJ, Caracta CF, Tantry SK. Efficacy and safety of olopatadine-mometasone combination nasal spray for the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2019 Jun;122(6):630-638.e3. doi: 10.1016/j.anai.2019.03.017. Epub 2019 Mar 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	GMM-2 NS	Unknown	25 ug	Intranasal
Comparator	GOM-NS	Unknown	665 ug	Intranasal
Subject	Mometasone furoate	Other / unclassified	25 ug	Intranasal
Subject	Olopatadine	Other / unclassified	665 ug	Intranasal