NCT01817790

Assessment of Fluticasone Propionate on Ocular Allergy Symptoms

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy of Once-Daily Fluticasone Propionate Aqueous Nasal Spray 200mcg for 14 Days on Ocular Symptoms Associated With Seasonal Allergic Rhinitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 626 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

This study is designed to investigate the efficacy of fluticasone propionate (FP) on ocular symptoms associated with allergic rhinitis (AR).

Detailed description

While the current FP approved indication for GSK marketed formulation is limited to the treatment of nasal symptoms, several large well-controlled studies in which FP maintained adequate control of nasal symptoms when administered in a dose of 200 micrograms (mcg) once-daily (QD) also suggested improvement in ocular symptoms. This study will employ a randomized, double-blind, parallel group, multi-center design that compares FP and placebo nasal sprays in subjects with seasonal allergic rhinitis (SAR) to assess the effectiveness on ocular symptoms associated with AR.

Conditions

• Allergic Rhinitis
• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Fluticasone propionate	Nasal spray formulation (200 mcg/day)
DRUG	Placebo	Vehicle for Fluticasone propionate aqueous nasal spray

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2013-03-25
• Last updated: 2014-04-03
• Results posted: 2014-04-03

Locations

1 site across 1 country: United States