Conditions: Seasonal Allergic Rhinitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 951
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Perrigo arm 2: Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Meda arm 3: Placebo nasal spray

Interventions: intervention 1: Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray intervention 2: Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray intervention 3: Placebo nasal spray
Intervention descriptions: intervention 1: 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate intervention 2: 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate intervention 3: Placebo nasal spray

Protocol document:
Prot_001.pdf: 
 
 
NCT02230696 
 
09-02-2014 

















































































































SAP_000.pdf: 
 
 
NCT02230696 
 
09-02-2014