NCT01018030

Dose Finding Study of Fluticasone Furoate Nasal Spray for Uncomplicated Acute Rhinosinusitis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 741 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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).

Detailed description

\- Rationale - Acute rhinosinusitis (ARS) is a condition caused by inflammation of the nose and the paranasal sinuses that generally lasts up to 4 weeks. Despite ARS being a self-limiting condition, untreated or inadequately treated sinus infection can lead to the development of complications. Uncomplicated ARS is a subset of ARS and is distinguished from the common cold by the persistence or the worsening of sinus inflammation after the usual period for recovery of viral infection of the nasal cavity (i.e., 10 days). Clinically the difference is based on the following criteria: symptoms are present at least 10 days but less than 4 weeks beyond the onset of upper respiratory symptoms OR symptoms worsen after 5 days from their onset. In the primary care settings, ARS is often treated empirically with antibiotics although they are shown to provide limited benefit in the uncomplicated ARS population. Alternatively, the use of an intranasal corticosteroid (INS) to control symptoms of uncomplicated ARS is plausible based on clinically proven ability to reduce inflammation and mucosal swelling. This study is a phase II study. * Objective - The objective of this study is to evaluate the safety and efficacy of two doses of FFNS (110 mcg once daily and 110 mcg twice daily) compared to placebo as monotherapy in the treatment of adult and adolescent subjects 12 years of age and older with uncomplicated ARS. * Study Design - This is a randomized, double-blind, placebo controlled, parallel group, multi-centre, 2-week treatment study. The study includes a 2-week post-treatment follow-up period. Approximately 720 subjects will be randomized to one of three treatment groups for a period of 14 days: FFNS 110 mcg QD, FFNS 110 mcg BID, and placebo nasal spray.

Conditions

• Sinusitis, Acute

Interventions

Type	Name	Description
DRUG	FFNS 110 mcg QD	Active Nasal Spray (AM) and Placebo Nasal Spray (PM)
DRUG	FFNS 110 mcg BID	Active Nasal Spray (AM) and Active Nasal Spray (PM)
DRUG	Placebo Nasal Spray	Placebo Nasal Spray (AM) and Placebo Nasal Spray (PM)

Timeline

• Start date: 2010-01-06
• Primary completion: 2010-07-01
• Completion: 2010-07-16
• First posted: 2009-11-23
• Last updated: 2017-05-17
• Results posted: 2011-04-12

Locations

87 sites across 12 countries: Bulgaria, Canada, Czechia, Estonia, Germany, Netherlands, Norway, Poland, Russia, Spain, Sweden, Ukraine