Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)

Summary

Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR).

Timeline

Start

2018-03-16

Primary completion

2018-11-14

Completion

2018-11-14

Outcome

Met primary endpoint

paper GSP301 showed clinically meaningful and statistically significant improvement in rTNSS vs placebo (-0.6; 95% confidence interval, -0.9 to -0.2; P = .001). PMID 35926824 ↗

release “in pediatric patients aged 6 to under 12 years of age met its primary endpoint” glenmarkpharma.com ↗

Publications

• Prenner BM, Amar NJ, Hampel FC Jr, Caracta CF, Wu W. Efficacy and safety of GSP301 nasal spray in children aged 6 to 11 years with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2022 Nov;129(5):618-626.e2. doi: 10.1016/j.anai.2022.07.029. Epub 2022 Aug 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mometasone	Other / unclassified	25 ug	Intranasal
Subject	Olopatadine	Other / unclassified	665 ug	Intranasal

Indications