Clinical Equivalence Study of Fluticasone Propionate Nasal Spray, 50 mcg/Actuation vs. Flonase in Allergic Rhinitis Patients

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.

Timeline

Start

2014-03-01

Primary completion

2014-07-14

Completion

2014-07-14

Drugs

Indications