NCT02246920

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

A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Compare the Therapeutic Equivalence of Fluticasone Propionate Nasal Spray, 50 mcg With Flonase® Nasal Spray in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,474 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Fluticasone propionate	50 mcg/actuation Nasal Spray
DRUG	Flonase®	50 mcg/actuation Nasal Spray
DRUG	Placebo	Inactive Nasal Spray

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-07-14
• Completion: 2014-07-14
• First posted: 2014-09-23
• Last updated: 2023-06-08
• Results posted: 2023-06-08

Locations

1 site across 1 country: United States