EQUIVALENCIA CLÍNICA ENTRE EL ROCIADOR NASAL DE PROPIONATO DE FLUTICASONA GENÉRICO Y COMERCIAL EN PACIENTES CON RINITIS ALÉRGICA

Abstract

Objective. The primary objective of this study was to establish the clinic equivalence of a new Fluticasone Propionate Aqueous Nasal Spray (FANS) compared to two commercially available active treatments of fluticasone propionate nasal spray (Flonase and Flixonase ) during the mountain cedar ( Juniperus ashei ) pollen season in Texas. Material and methods. This was a multicenter, randomized, double-blind, double-dummy, active-controlled and placebo-controlled, parallel group study designed to investigate the safety and efficacy of FANS (200 mcg QD), Flonase and Flixonase (200 mcg QD) compared to placebo administered for 13 to 15 days. Patients recorded the total nasal symptoms dcores (TNSS) in a diary in the morning and evening every day. The primary endpoint was the patient-rated am and pm TNSS +1. Other key efficacy endpoints were patient-rated AM TNSS+1, patient-rated PM TNSS+1, and safety. Results. Mean TNSS values for Flonase and Flixonase were not statistically significantly different from FANS during any study day, over the entire treatment period, or at endpoint. Bioequivalence between FANS and Flonase (ratio= 0.98, 90% CI 0.91 to 1.06) as well as FANS and Flixonase (ratio=1.02, 90% CI 0.94 to 1.10) was demonstrated for the primary endpoint [Patient-Rated am and pm TNSS +1] as well as for the other key efficacy endpoints. Conclusions. The findings from this study support that FANS 200 mcg QD is therapeutically bioequivalent to both Flonase and Flixonase in the control of the symptoms of seasonal allergic rhinitis.