At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 741 enrolled
Drug / intervention
FFNS 110 mcg QD +2 moredrug
Likely dose
FFNS 110 mcg QDfrom 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 Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, 2-week Treatment Study to Evaluate the Safety and Efficacy of Fluticasone Furoate Nasal Spray 110 mcg in the Treatment in the Treatment of Uncomplicated Acute Rhinosinusitis in Adults and Adolescents >= 12 Years of Age
In Brief
A Phase 2 clinical trial evaluating FFNS 110 mcg QD, FFNS 110 mcg BID, and 1 other intervention for Sinusitis, Acute. Completed, enrolled 741 participants across 87 sites in 12 countries.
Detailed Summary
The purpose of this study is to assess the safety and efficacy of fluticasone furoate nasal spray (FFNS), without the use of an antibiotic, in the treatment of adult and adolescent subjects who are 12 years of age and older with uncomplicated acute rhinosinusitis (ARS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSinusitis, Acute
CountriesBulgaria, Canada, Czechia, Estonia, Germany, Netherlands, Norway, Poland, Russia, Spain, Sweden, Ukraine
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2009
Enrollment StartJan 2010
Primary CompletionJul 2010
Study CompletionJul 2010
TodayJul 2026
First PostedNov 23, 2009
Enrollment StartJan 6, 2010
Primary CompletionJul 1, 2010
Study CompletionJul 16, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.6 years ago
Interventions
FFNS 110 mcg QDdrug
Active Nasal Spray (AM) and Placebo Nasal Spray (PM)
FFNS 110 mcg BIDdrug
Active Nasal Spray (AM) and Active Nasal Spray (PM)
Placebo Nasal Spraydrug
Placebo Nasal Spray (AM) and Placebo Nasal Spray (PM)