Efficacy and Safety of Fixed Dose Combination (FDC) of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray (Molo; Also Referred as GSP 301) in the Treatment of Seasonal Allergic Rhinitis (SAR)

Phase 2 Completed 180 enrolled Glenmark Pharmaceuticals Ltd. India

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A single-center, double-blind, placebo-controlled study of FDC olopatadine hydrochloride and mometasone furoate nasal spray (Molo; also referred as GSP 301) was conducted in subjects with seasonal allergic rhinitis. In this study, the efficacy and safety of two regimens (BID and QD) of the FDC (i.e. Molo 1 and Molo 2) were evaluated compared to placebo nasal spray, DYMISTA® and PATANASE®.

Timeline

Start: 2014-01-27
Primary completion: 2014-02-28
Completion: 2014-02-28

Publications

Patel P, Salapatek AM, Tantry SK. Effect of olopatadine-mometasone combination nasal spray on seasonal allergic rhinitis symptoms in an environmental exposure chamber study. Ann Allergy Asthma Immunol. 2019 Feb;122(2):160-166.e1. doi: 10.1016/j.anai.2018.10.011. Epub 2018 Oct 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Azelastine	Small molecule	0.137 mg	Intranasal
Comparator	Fluticasone	Other / unclassified	0.05 mg	Intranasal
Subject	Mometasone	Other / unclassified	0.025 mg	Intranasal
Subject	Mometasone	Other / unclassified	0.05 mg	Intranasal
Subject	Olopatadine	Other / unclassified	0.665 mg	Intranasal

Efficacy and Safety of Fixed Dose Combination (FDC) of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray (Molo; Also Referred as GSP 301) in the Treatment of Seasonal Allergic Rhinitis (SAR)

Summary

Timeline

Publications

Drugs

Indications