At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi-Site Study to Compare the Clinical Equivalence of Fluticasone Furoate Nasal Spray (Lek Pharmaceuticals) With Veramyst® Nasal Spray (GlaxoSmithKline) in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
In Brief
A Phase 3 clinical trial evaluating Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals), Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray, and 1 other intervention for Rhinitis, Allergic, Seasonal. Completed, enrolled 727 participants across 7 sites.
Detailed Summary
This study compared the safety and efficacy of a generic fluticasone furoate (Lek Pharmaceuticals) nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations were tested for superiority against a placebo nasal spray.
Study Details
Timeline
Interventions
Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.
Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.
Placebo nasal spray administered once daily (4 actuations) for 14 days.