NCT02230696

Comparative Safety and Efficacy of Two Steroid Treatments in the Relief of the Symptoms of Seasonal Allergic Rhinitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 951 (actual)
• Sponsor: Padagis LLC · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To compare safety and efficacy of Perrigo's steroid drug product compared with an FDA approved steroid drug product in the treatment of subjects with seasonal allergic rhinitis.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray	137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate
DRUG	Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray	137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate
DRUG	Placebo nasal spray	Placebo nasal spray

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2014-09-03
• Last updated: 2021-10-22
• Results posted: 2021-03-15

Locations

30 sites across 1 country: United States