Conditions: Seasonal Allergic Rhinitis
Keywords: Bioequivalence Allergic Rhinitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1474
Healthy volunteers: no

Brief summary:
This double-blind, randomized, placebo-controlled, parallel group, multi-site study has been designed to compare the safety and efficacy of a generic Fluticasone propionate Nasal Spray, 50 mcg (Teva Pharmaceuticals USA) to the FDA Reference Listed Drug, Flonase® (fluticasone propionate) 50 mcg nasal spray (GlaxoSmithKline), in the relief of the signs and symptoms of Seasonal Allergic Rhinitis. Additionally, both the test and reference formulations will be tested for superiority against a placebo nasal spray.

Detailed description:

Arms:
arm 1: Fluticasone propionate Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days arm 2: Flonase® (fluticasone propionate) Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days arm 3: Saline Placebo Nasal Spray; 4 total sprays/day for 14 days

Interventions: intervention 1: Fluticasone propionate intervention 2: Flonase® intervention 3: Placebo
Intervention descriptions: intervention 1: 50 mcg/actuation Nasal Spray intervention 2: 50 mcg/actuation Nasal Spray intervention 3: Inactive Nasal Spray

Protocol document: