Abstract

Background Four previously published trials assessed the efficacy of MP29-02* (a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP) in an advanced delivery system) in seasonal allergic rhinitis (SAR) [1,2]. The first study compared MP29-02* to marketed AZE and FP [2]. The others compared MP29-02* to AZE and FP in the MP29-02* vehicle and delivery device (i.e. re-formulated comparators) [1]. FP contained within MP29-02* has a unique PK fingerprint [3]. The aim of this analysis was to demonstrate that formulation/device contribute to MP29-02*’s clinical efficacy.

Highlights

  • Four previously published trials assessed the efficacy of MP29-02* (a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP) in an advanced delivery system) in seasonal allergic rhinitis (SAR) [1,2]

  • The formulation/device effect of MP29-02* was quantified by comparing treatment differences obtained with MP29-02* vs marketed FP and MP29-02* vs reformulated FP for these endpoints

  • For all efficacy variables assessed, the treatment difference was greater for MP29-02* vs marketed-FP than for MP2902* vs re-formulated-FP

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Summary

Introduction

Four previously published trials assessed the efficacy of MP29-02* (a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP) in an advanced delivery system) in seasonal allergic rhinitis (SAR) [1,2]. The first study compared MP29-02* to marketed AZE and FP [2]. The others compared MP29-02* to AZE and FP in the MP29-02* vehicle and delivery device (i.e. re-formulated comparators) [1]. FP contained within MP29-02* has a unique PK fingerprint [3]. The aim of this analysis was to demonstrate that formulation/device contribute to MP29-02*’s clinical efficacy

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