At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 705 enrolled
Drug / intervention
Fluticasone Propionatedrug
Likely dose
Fluticasone Propionate 400 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Fluticasone Propionate for Chronic Sinusitis With or Without Nasal Polyps. Completed, enrolled 705 participants across 18 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartSep 2013
Primary CompletionMar 2015
TodayJul 2026
First PostedJun 19, 2012
Enrollment StartSep 1, 2013
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 14.0 years ago
Interventions
Fluticasone Propionatedrug
Fluticasone Propionate 400 μg