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

William Berger (1, 2) , Eli O. Meltzer (3) , Niran Amar (4) , Adam T. Fox (5) , Jocelyne Just (6, 7) , Antonella Muraro (8) , Antonio Nieto (9) , Erkka Valovirta (10) , Magnus Wickman (11, 12) , Jean Bousquet (13, 14, 15)

1 Allergy & Asthma Associates
2 Division of Basic Clinical Immunology
3 Allergy & Asthma Medical Group & Research Center
4 Allergy & Asthma Research Institute
5 King‘s College London
6 CHU Trousseau [APHP]
7 iPLESP - Institut Pierre Louis d'Epidémiologie et de Santé Publique
8 Department of Mother and Child Health
9 Pediatric Allergy and Pneumology Unit
10 Department of Lung Diseases & Clinical Allergology
11 Sachs' Children's Hospital
12 National Institute of Environmental Medicine
13 CHU de Montpellier
14 VIMA - Vieillissement et Maladies chroniques : approches épidémiologique et de santé publique
15 MACVIA-LR - Contre les MAladies Chroniques pour un VIeillissement Actif en Languedoc-Roussillon

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.

Mots clés: azelastine; assessment; children; dymista; fluticasone propionate; MP-AzeFlu; seasonal allergic rhinitis

Domaines: Pédiatrie

William Berger, Eli O. Meltzer, Niran Amar, Adam T. Fox, Jocelyne Just, et al.. Efficacy of MP-AzeFlu in children with seasonal allergic rhinitis: Importance of paediatric symptom assessment. Pediatric Allergy and Immunology, 2016, 27 (2), pp.126-133. ⟨10.1111/pai.12540⟩. ⟨hal-01285547⟩