At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 223 enrolled
Drug / intervention
Fluticasone Propionatedrug
Likely dose
Not stated in 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.
12-Month OL Evaluating the Safety of Intranasal Administration Fluticasone BID Using OptiNose Device in Subjects With CS With or Without Nasal Polyps
In Brief
A Phase 3 clinical trial evaluating Fluticasone Propionate for Nasal Polyps. Completed, enrolled 223 participants across 16 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 12-month open-label treatment phase. The duration of each subject's participation is approximately 53 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasal Polyps
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartSep 2013
Primary CompletionAug 2015
Study CompletionOct 2015
TodayJul 2026
First PostedJun 19, 2012
Enrollment StartSep 1, 2013
Primary CompletionAug 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.0 years ago
Interventions
Fluticasone Propionatedrug
Using Optinose Exhalation Delivery System