MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate) in the treatment of seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial of efficacy and safety

Allergy Asthma Proc. 2012 Jul-Aug;33(4):324-32. doi: 10.2500/aap.2012.33.3587.

Abstract

Many patients with allergic rhinitis (AR) have uncontrolled symptoms despite available treatment options. This study was designed to evaluate the efficacy and safety of MP29-02 (a novel intranasal formulation of fluticasone propionate [FP] and azelastine [AZ] hydrochloride), compared with monotherapy with FP, AZ, and placebo sprays for the treatment of seasonal allergic rhinitis (SAR). This 2-week randomized, double-blind, placebo-controlled trial was conducted in 779 patients with moderate-to-severe SAR. Treatments were administered 1 spray/nostril twice daily in the same vehicle and delivery device. Daily doses of AZ and FP were 548 and 200 micrograms, respectively. The primary efficacy variable was the 12-hour reflective total nasal symptom score (rTNSS), consisting of nasal congestion, sneezing, itchy nose, and runny nose. Secondary efficacy variables were (1) 12-hour reflective individual nasal symptom scores; (2) onset of action; (3) 12-hour reflective total ocular symptom score (rTOSS), including itchy eyes, watery eyes, and red eyes; and (4) the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) overall score. MP29-02 significantly reduced the mean rTNSS from baseline by -5.54 points compared with FP (-4.55; p = 0.038), AZ (-4.54; p = 0.032), and placebo (-3.03; p < 0.001), improving the rTNSS by 39% beyond the contribution of FP. All individual nasal symptoms contributed to the efficacy of MP29-02. Onset of action was within 30 minutes. MP29-02 significantly improved rTOSS compared with placebo, provided a clinically important improvement in the overall RQLQ score, and was well tolerated. In this study, MP29-02 provided more complete symptom relief than two widely used first-line AR treatments and was well tolerated.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Administration, Intranasal
  • Adolescent
  • Adult
  • Aged
  • Androstadienes / administration & dosage*
  • Androstadienes / adverse effects*
  • Androstadienes / therapeutic use
  • Anti-Allergic Agents / administration & dosage*
  • Anti-Allergic Agents / adverse effects*
  • Anti-Allergic Agents / therapeutic use
  • Child
  • Double-Blind Method
  • Drug Combinations
  • Female
  • Fluticasone
  • Humans
  • Male
  • Middle Aged
  • Phthalazines / administration & dosage*
  • Phthalazines / adverse effects*
  • Phthalazines / therapeutic use
  • Quality of Life
  • Rhinitis, Allergic, Seasonal / drug therapy*
  • Rhinitis, Allergic, Seasonal / physiopathology
  • Severity of Illness Index
  • Surveys and Questionnaires
  • Treatment Outcome
  • Young Adult

Substances

  • Androstadienes
  • Anti-Allergic Agents
  • Drug Combinations
  • MP29-02
  • Phthalazines
  • Fluticasone
  • azelastine