NCT02249663

Clinical Equivalence of Azelastine Hydrochloride and Fluticasone Propionate, 137/50 mcg Nasal Spray to Dymista™

A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multi-Site Study to Evaluate the Therapeutic Equivalence of Azelastine Hydrochloride and Fluticasone Propionate, 137/50 mcg Nasal Spray, to Dymista™ Nasal Spray

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,535 (estimated)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the therapeutic equivalence of a test formulation of Azelastine hydrochloride and Fluticasone propionate Nasal Spray to the reference listed drug, Dymista™ Nasal Spray in the relief of the signs and symptoms of Seasonal Allergic Rhinitis.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Azelastine hydrochloride and Fluticasone propionate	137/50 mcg Nasal Spray
DRUG	Dymista™	137/50 mcg Nasal Spray
OTHER	Placebo	Nasal spray with no pharmaceutically active content

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-02-01
• First posted: 2014-09-25
• Last updated: 2014-09-25

Locations

1 site across 1 country: United States