NCT02279563

A Study Comparing the Bioequivalence of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray (Apotex, Inc.) to That of Dymista™ Nasal Spray (Meda Pharmaceuticals, Inc.) in the Treatment of Seasonal Allergic Rhinitis

A Randomized, Double-blind, Placebo-controlled,Parallel-group Study Comparing the Bioequivalence of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray (Apotex, Inc.) to That of Dymista™ Nasal Spray (Meda Pharmaceuticals, Inc. )in the Treatment of Seasonal Allergic Rhinitis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 595 (actual)
• Sponsor: Apotex Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the equivalence of generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray with that of the marketed drug, Dymista™ Nasal Spray, in the treatment of seasonal allergic rhinitis, and to evaluate the safety and tolerability of generic Azelastine Hydrochloride and Fluticasone Propionate nasal spray compared with Dymista™ nasal spray.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Azelastine HCl and Fluticasone Propionate Nasal Spray, 137 µg/50 µg per spray	During the placebo lead-in period, the placebo nasal spray was administered via nasal inhalation with one spray in each nostril twice daily for 7days. During the randomized treatment period, the investigational products (experimental, active comparator and placebo nasal spray) were administered via nasal inhalation with one spray in each nostril twice daily for 14 days
DRUG	Dymista™ Nasal Spray
DRUG	Placebo

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-02-01
• First posted: 2014-10-31
• Last updated: 2014-10-31