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Efficacy of MP-AzeFlu in children with seasonal allergic rhinitis: Importance of paediatric symptom assessment.
Pediatr Allergy Immunol. 2016 Mar; 27(2):126-33.PA

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+Show Affiliations

Division of Basic Clinical Immunology, School of Medicine, University of California, Irvine, CA, USA. Allergy and Asthma Associates, Mission Viejo, CA, USA.Allergy and Asthma Medical Group and Research Center, San Diego, CA, USA.Allergy & Asthma Research Institute, Waco, TX, USA.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.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.Department of Mother and Child Health, Padua General University Hospital, Padua, Italy.Pediatric Allergy and Pneumology Unit, Children's Hospital La Fe, Valencia, Spain.Department of Lung Diseases & Clinical Allergology, University of Turku & Terveystalo Allergy Clinic, Turku, Finland.National Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden. Department of Pediatrics, Sachs' Children's Hospital, Stockholm, Sweden.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.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

26928753

Citation

Berger, William, et al. "Efficacy of MP-AzeFlu in Children With Seasonal Allergic Rhinitis: Importance of Paediatric Symptom Assessment." Pediatric Allergy and Immunology : Official Publication of the European Society of Pediatric Allergy and Immunology, vol. 27, no. 2, 2016, pp. 126-33.
Berger W, Meltzer EO, Amar N, et al. Efficacy of MP-AzeFlu in children with seasonal allergic rhinitis: Importance of paediatric symptom assessment. Pediatr Allergy Immunol. 2016;27(2):126-33.
Berger, W., Meltzer, E. O., Amar, N., Fox, A. T., Just, J., Muraro, A., Nieto, A., Valovirta, E., Wickman, M., & Bousquet, J. (2016). Efficacy of MP-AzeFlu in children with seasonal allergic rhinitis: Importance of paediatric symptom assessment. Pediatric Allergy and Immunology : Official Publication of the European Society of Pediatric Allergy and Immunology, 27(2), 126-33. https://doi.org/10.1111/pai.12540
Berger W, et al. Efficacy of MP-AzeFlu in Children With Seasonal Allergic Rhinitis: Importance of Paediatric Symptom Assessment. Pediatr Allergy Immunol. 2016;27(2):126-33. PubMed PMID: 26928753.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of MP-AzeFlu in children with seasonal allergic rhinitis: Importance of paediatric symptom assessment. AU - Berger,William, AU - Meltzer,Eli O, AU - Amar,Niran, AU - Fox,Adam T, AU - Just,Jocelyne, AU - Muraro,Antonella, AU - Nieto,Antonio, AU - Valovirta,Erkka, AU - Wickman,Magnus, AU - Bousquet,Jean, PY - 2015/12/17/accepted PY - 2016/3/2/entrez PY - 2016/3/2/pubmed PY - 2016/12/15/medline KW - MP-AzeFlu KW - assessment KW - azelastine KW - children KW - dymista KW - fluticasone propionate KW - seasonal allergic rhinitis SP - 126 EP - 33 JF - Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology JO - Pediatr Allergy Immunol VL - 27 IS - 2 N2 - 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. SN - 1399-3038 UR - https://www.unboundmedicine.com/medline/citation/26928753/Efficacy_of_MP_AzeFlu_in_children_with_seasonal_allergic_rhinitis:_Importance_of_paediatric_symptom_assessment_ L2 - https://doi.org/10.1111/pai.12540 DB - PRIME DP - Unbound Medicine ER -