drugset / Trial / NCT03960580

Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis Without the Presence of Nasal Polyps

NCT03960580

Phase 3 Completed 223 enrolled Optinose US Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of intranasal administration of 186 and 372 μg twice daily (BID) of OPN-375 in subjects with chronic Rhinosinusitis (CRS) without nasal polyps

Timeline

Start
2019-06-06
Primary completion
2022-05-04
Completion
2022-05-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluticasone Other / unclassified 186 ug Other
Comparator Fluticasone Other / unclassified 372 ug Other