drugset / Trial / NCT02631551

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

NCT02631551 ↗

Phase 3 Completed 1180 enrolled Glenmark Specialty S.A.
RandomizedParallel-groupDouble-blindTreatment

Summary

Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo NS over 14 days of study treatment

Timeline

Start
2016-03
Primary completion
2016-07
Completion
2016-07

Outcome

Met primary endpoint

paper GSP301 significantly improved average A.M. and P.M. rTNSS versus placebo (least squares mean difference -0.98 [95% confidence interval, -1.38 to -0.57]; p < 0.001) PMID 31053180 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Mometasone furoate Other / unclassified 25 ug Intranasal
Subject Olopatadine Other / unclassified 665 ug Intranasal