Conditions: Allergic Rhinitis Seasonal Allergic Rhinitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 626
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning. arm 2: Two sprays of placebo per nostril to be administered in morning.

Interventions: intervention 1: Fluticasone propionate intervention 2: Placebo
Intervention descriptions: intervention 1: Nasal spray formulation (200 mcg/day) intervention 2: Vehicle for Fluticasone propionate aqueous nasal spray

Protocol document: