Vol. 161, No. 4, 2013

Issue release date: July 2013

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Int Arch Allergy Immunol 2013;161:369-377
(DOI:10.1159/000351404)

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Original Paper

Clinically Relevant Effect of a New Intranasal Therapy (MP29-02) in Allergic Rhinitis Assessed by Responder Analysis Meltzer E.a · Ratner P.c · Bachert C.g · Carr W.b · Berger W.b · Canonica G.W.h ·Hadley J.e · Lieberman P.f · Hampel F.C.d · Mullol J.i · Munzel U.j · Price D.m ·Scadding G.n · Virchow J.C.k · Wahn U.l · Murray R.o · Bousquet J.p  aAllergy and Asthma Medical Group and Research Center, San Diego, Calif.,bAllergy and Asthma Associates of Southern California, Mission Viejo, Calif.,cSylvana Research, San Antonio, Tex.,dCentral Texas Health Research, New Braunfels, Tex.,eUniversity of Rochester Medical Center, Rochester, N.Y.,fUniversity of Tennessee College of Medicine, Memphis, Tenn., USA;gUpper Airways Research Laboratory, Ghent University Hospital, Ghent, Belgium;hUniversity of Genoa, IRCCS AOU S. Martino, Genoa, Italy;iHospital Clínic, IDIBAPS, CIBERES, Barcelona, Spain;jMEDA Pharma GmbH & Co. KG, Bad Homburg,kUniversity Hospital, Rostock, andlChildren's Hospital Charité, Berlin, Germany; mUniversity of Aberdeen, Aberdeen, andnThe Royal National Throat, Nose and Ear Hospital, London, UK;oMedScript, Dundalk, Ireland;pArnaud de Villeneuve University Hospital, Montpellier and Inserm CESP1018, Montpellier, France  Corresponding Author

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 Outline

• Key Words

• Abstract
• Introduction
• Background and Objectives
• Scientific Background and Explanation of Rationale
• Specific Objectives
• Material and Methods
• Participants
• Planned Interventions and Timing
• Efficacy Variables
• Sample Size, Randomization and Blinding
• Statistical Analyses
• Results
• Patients
• Outcomes
• Original Analysis
• Post hoc Analyses
• Discussion
• Acknowledgements
• References

• Author Contacts
• Article Information
• Publication Details
• Drug Dosage / Copyright

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  Key Words


• Allergic rhinitis
• Azelastine
• Fluticasone
• MP29-02
• Responder analysis
• Severe chronic upper airway disease 


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  Abstract

Background: It is unclear what constitutes a clinically meaningful response for allergic rhinitis (AR) outcomes. The objectives of these post hoc analyses were (1) to define a clinically meaningful response using novel efficacy analyses (including a responder analysis), and (2) to compare the efficacy of MP29-02 [a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP)] with commercially available FP, AZE and placebo in seasonal AR (SAR) patients, using these novel analyses.Methods: 610 moderate-to-severe SAR patients (≥12 years old) were randomized into a double-blind, placebo-controlled, 14-day, parallel-group trial. Change from baseline in the reflective total nasal symptom score (rTNSS) over 14 days was the primary outcome. Post hoc endpoints included the sum of nasal and ocular symptoms (rT7SS), efficacy by disease severity and by predominant nasal symptom, and a set of responder analyses.Results: MP29-02 most effectively reduced rT7SS (relative greater improvement: 52% to FP; 56% to AZE) and both nasal and ocular symptoms irrespective of severity. More MP29-02 patients achieved a ≥30, ≥50, ≥60, ≥75 and ≥90% rTNSS reduction, which occurred days faster than with either active comparator; MP29-02 alone was superior to placebo at the ≥60% (or higher) threshold. One in 2 MP29-02 patients achieved a ≥50% rTNSS reduction and 1 in 6 achieved complete/near-to-complete response. Only MP29-02 was consistently superior to placebo for all patients, whatever their predominant symptom. Conclusions: MP29-02 provided faster and more complete symptom control than first-line therapies. It was consistently superior irrespective of severity, response criteria or patient-type, and may be considered the drug of choice for moderate-to-severe AR. These measures define a new standard for assessing relevance in AR.

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