Revista Peruana de Medicina Experimental y Salud Publica
ISSN 1726-4634 versión impresa
BRANDI, Vikki y STAHL, Edmundo G. Equivalencia clínica entre el rociador nasal de propionato de fluticasona genérico y comercial en pacientes con rinitis alérgica: Clinical equival ence between generic and branded fluticasone propionate nasal spray in patients with alergic rhinitis. Rev. perú. med. exp. salud publica, oct./dic. 2009, vol.26, no.4, p.432-440. ISSN 1726-4634.
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.
Palabras llave: Rhinitis; allergic; seasonal; Fluticasone; Drugs; generic; Therapeutic Equivalency.
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