drugset / Trial / NCT01623310

12-Month OL Intranasal Fluticasone Propionate BID Using OptiNose Device

NCT01623310

Phase 3 Completed 223 enrolled Optinose US Inc.
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, multicenter study designed to assess the safety of intranasal administration of 400 μg of fluticasone propionate twice a day delivered by the OptiNose device in subjects with chronic sinusitis with or without nasal polyps. The study consists of an up-to-7-day pretreatment phase followed a 12-month open-label treatment phase. The duration of each subject's participation is approximately 53 weeks.

Timeline

Start
2013-09
Primary completion
2015-08
Completion
2015-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone propionate Other / unclassified 400 ug Intranasal

Indications