Efficacy of MP-AzeFlu in children with seasonal allergic rhinitis: Importance of paediatric symptom assessment

Pediatr Allergy Immunol. 2016 Mar;27(2):126-33. doi: 10.1111/pai.12540.

Abstract

Background: This study aimed to assess the efficacy of MP-AzeFlu (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate in a single spray) in children with seasonal allergic rhinitis (SAR) and explore the importance of child symptom severity assessment in paediatric allergic rhinitis (AR) trials.

Methods: A total of 348 children (4-11 years) with moderate/severe SAR were randomized into a double-blind, placebo-controlled, 14-day, parallel-group trial. Efficacy was assessed by changes from baseline in reflective total nasal symptom score (rTNSS), reflective total ocular symptom score (rTOSS) and individual symptom scores over 14 days (children 6-11 years; n = 304), recorded by either children or caregivers. To determine whether a by-proxy effect existed, efficacy outcomes were assessed according to degree of child/caregiver rating. Moreover, total Paediatric Rhinitis Quality of Life Questionnaire (PRQLQ) score was compared between the groups.

Results: A statistically superior, clinically relevant efficacy signal of MP-AzeFlu versus placebo was apparent for PRQLQ overall score (diff: -0.29, 95% CI -0.55, -0.03; p = 0.027), but not for rTNSS (diff: -0.80; 95% CI: -1.75; 0.15; p = 0.099). However, as the extent of children's self-rating increased, so too did the treatment difference between MP-AzeFlu and placebo; MP-AzeFlu provided significantly better relief than placebo for rTNSS (p = 0.002), rTOSS (p = 0.009) and each individual nasal and ocular symptom assessed (except rhinorrhoea; p = 0.064) when children mostly rated their own symptoms.

Conclusions: MP-AzeFlu is an effective treatment for AR in childhood. Caregivers are less able than children to accurately assess response to treatment with available tools. A simple paediatric-specific tool to assess efficacy in AR trials in children is needed.

Keywords: MP-AzeFlu; assessment; azelastine; children; dymista; fluticasone propionate; seasonal allergic rhinitis.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Caregivers
  • Child
  • Child, Preschool
  • Disease Progression
  • Drug Combinations
  • Female
  • Fluticasone / therapeutic use*
  • Humans
  • Male
  • Nasal Sprays
  • Phthalazines / therapeutic use*
  • Rhinitis, Allergic, Seasonal / drug therapy*
  • Severity of Illness Index
  • Surveys and Questionnaires
  • Symptom Assessment

Substances

  • Drug Combinations
  • Nasal Sprays
  • Phthalazines
  • Fluticasone
  • azelastine