Conditions: Seasonal Allergic Rhinitis (SAR)
Keywords: GSP 301 nasal spray for the treatment of Seasonal Allergic Rhinitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 446
Healthy volunteers: no

Brief summary:
Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR).

Detailed description:

Arms:
arm 1: Fixed dose combination of olopatadine hydrochloride 665 μg and mometasone furoate 25 μg NS arm 2: GSP 301 Placebo nasal spray

Interventions: intervention 1: GSP 301 NS intervention 2: GSP 301 Placebo NS
Intervention descriptions: intervention 1: 1 spray in each nostril twice daily for 14 days intervention 2: 1 spray in each nostril twice daily for 14 days

Protocol document:
Prot_000.pdf: 
 
   
 
Confidential 
 
 
Page 1 of 1 
 
 
A Double-Blind, Randomized, Parallel-Group Study to Evaluate the Efficacy, Safety and 
Tolerability of Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo 
Nasal Spray in Pediatric Subjects (Aged 6 to Under 12 Years) With Seasonal Allergic 
Rhinitis (SAR)  
 
Identifiers                   NCT03463031 
Date of Document     18 July 2018 





















































































































































































SAP_001.pdf: