title: Efficacy of MP-AzeFlu in children with seasonal allergic rhinitis: Importance of paediatric symptom assessment.
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.
authors.affiliation: Division of Basic Clinical Immunology, School of Medicine, University of California, Irvine, CA, USA.|Allergy and Asthma Associates, Mission Viejo, CA, USA.
authors.forename: William
authors.initials: W
authors.lastname: Berger
authors.affiliation: Allergy and Asthma Medical Group and Research Center, San Diego, CA, USA.
authors.forename: Eli O
authors.initials: EO
authors.lastname: Meltzer
authors.affiliation: Allergy & Asthma Research Institute, Waco, TX, USA.
authors.forename: Niran
authors.initials: N
authors.lastname: Amar
authors.affiliation: King's College London, MRC & Asthma UK centre in Allergic Mechanisms of Asthma, Division of Asthma, Allergy and Lung Biology, Guy's and St Thomas' NHS Foundation Trust, London, UK.
authors.forename: Adam T
authors.initials: AT
authors.lastname: Fox
authors.affiliation: Allergology Department, Centre de l'Asthme et des Allergies, Hôpital d'Enfants Armand-Trousseau (APHP) -APHP, Paris, France.|Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Equipe EPAR, Paris, France.
authors.forename: Jocelyne
authors.initials: J
authors.lastname: Just
authors.affiliation: Department of Mother and Child Health, Padua General University Hospital, Padua, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Muraro
authors.affiliation: Pediatric Allergy and Pneumology Unit, Children's Hospital La Fe, Valencia, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Nieto
authors.affiliation: Department of Lung Diseases & Clinical Allergology, University of Turku & Terveystalo Allergy Clinic, Turku, Finland.
authors.forename: Erkka
authors.initials: E
authors.lastname: Valovirta
authors.affiliation: National Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.|Department of Pediatrics, Sachs' Children's Hospital, Stockholm, Sweden.
authors.forename: Magnus
authors.initials: M
authors.lastname: Wickman
authors.affiliation: University Hospital, Montpellier, France.|MACVIA-LR, Contre les Maladies Chronique pour un Vieillissement Actif en Languedoc Roussilon, European Innovation Partnership on Active and Healthy Aging Reference Site, Montpellier, France.|INSERM, VIMA: Ageing and chronic diseases. Epidemiological and public health approaches, U1168, Paris, France.|UVSQ UMR-S1168, Universite Versailles St-Quentin-en-Yvelines, Versailles, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Bousquet
mesh_terms: D017028:Caregivers; D002648:Child; D002675:Child, Preschool; D018450:Disease Progression; D004338:Drug Combinations; D005260:Female; D000068298:Fluticasone / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D059085:Nasal Sprays; D010793:Phthalazines / Q000627:therapeutic use*; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D063189:Symptom Assessment
chemical_list: D004338:Drug Combinations; D059085:Nasal Sprays; D010793:Phthalazines; D000068298:Fluticasone; C020976:azelastine
keywords: MP-AzeFlu; assessment; azelastine; children; dymista; fluticasone propionate; seasonal allergic rhinitis