drugset / Trial / NCT03781804

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

NCT03781804

Phase 3 Completed 332 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 (CS) with or without nasal polyps.

Timeline

Start
2018-11-27
Primary completion
2022-01-19
Completion
2022-01-19

Drugs

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