NCT01623323

Study Evaluating the Safety of Intranasal Administration of 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Chronic Sinusitis With or Without Nasal Polyps

A 3-Month Open-Label Multicenter Study Evaluating the Safety of Intranasal Administration of 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Chronic Sinusitis With or Without Nasal Polyps

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 705 (actual)
• Sponsor: Optinose US Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 3-month open-label treatment phase. The duration of each subject's participation is approximately 13 weeks.

Conditions

• Chronic Sinusitis With or Without Nasal Polyps

Interventions

Type	Name	Description
DRUG	Fluticasone Propionate	Fluticasone Propionate 400 μg

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2012-06-19
• Last updated: 2016-08-29
• Results posted: 2016-03-01

Locations

18 sites across 1 country: United States