Clinically Relevant Effect of a New Intranasal Therapy (MP29-02) in Allergic Rhinitis Assessed by Responder Analysis

Eli Meltzer, Paul Ratner, Claus Bachert, Warner Carr, William Berger, G. Walter Canonica, James Hadley, Phil Lieberman, Frank C. Hampel, Joaquim Mullol, Ullrich Munzel, David Price, Glenis Scadding, J. Christian Virchow, Ulrich Wahn, Ruth Murray, Jean Bousquet* (Corresponding Author)

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

81 Citations (Scopus)

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.
Original languageEnglish
Pages (from-to)369-377
Number of pages9
JournalInternational Archives of Allergy and Immunology
Volume161
Issue number4
Early online date4 May 2013
DOIs
Publication statusPublished - Jul 2013

Keywords

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

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