At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 323 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.
A 16-Week Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (Bid) Using a Novel Bi-directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-week, Open-label Extension Phase to Assess Safety
In Brief
A Phase 3 clinical trial evaluating Fluticasone propionate for Bilateral Nasal Polyposis. Completed, enrolled 323 participants across 10 sites.
Detailed Summary
The primary objective of this study was to compare the efficacy of intranasal administration of 100, 200, and 400 μg twice daily (bid) of fluticasone propionate, delivered by the Optinose device, with matching placebo in subjects with bilateral nasal polyposis and nasal congestion.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBilateral Nasal Polyposis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartOct 2013
Primary CompletionMay 2015
Study CompletionJul 2015
TodayJul 2026
First PostedJun 21, 2012
Enrollment StartOct 30, 2013
Primary CompletionMay 11, 2015
Study CompletionJul 3, 2015
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 14.0 years ago
Interventions
Fluticasone propionatedrug
Delivered via Optinose Exhalation Delivery System