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

PHASE2UnknownINTERVENTIONAL
Enrollment

595

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

February 28, 2014

Conditions
Seasonal Allergic Rhinitis
Interventions
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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Apotex Inc.

INDUSTRY