NCT01279057

A Study Comparing Two Fluticasone Furoate Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 727 (actual)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study was designed as a double-blind, randomized, placebo-controlled, parallel group, multi-site to compare the clinical equivalence of the test formulation of fluticasone furoate, 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals d.d.) with the reference formulation Veramyst® nasal spray (GlaxoSmithKline) in the relief of the signs and symptoms of seasonal allergic rhinitis. Participants who met the inclusion/exclusion criteria entered a 7-day placebo lead-in period. Following this placebo lead-in period, on Day 1 participants who continued to meet eligibility criteria were randomly assigned in a 2:2:1 ratio to one of three treatment groups (Test Product:Reference Product:Placebo) for 14 days of treatment. In all treatment groups, participants were instructed to administer the study drug once daily at approximately the same time each day. A single dose of 110 mcg was 4 actuations, each containing 27.5 mcg per actuation. Patients were instructed to administer the 4 actuations alternating between right and left nostril, such that 2 actuations were not administered back to back to the same nostril.

Conditions

• Rhinitis, Allergic, Seasonal

Interventions

Type	Name	Description
DRUG	Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals)	Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.
DRUG	Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray	Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.
DRUG	Placebo	Placebo nasal spray administered once daily (4 actuations) for 14 days.

Timeline

• Start date: 2010-12-27
• Primary completion: 2011-02-08
• Completion: 2011-02-08
• First posted: 2011-01-19
• Last updated: 2021-02-03
• Results posted: 2021-02-03

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study