Allergic rhinitis (AR) affects up to 14.6% of the paediatric population. Whilst a recent Cochrane review has considered the evidence for intranasal corticosteroids as `weak and unreliable’ in paediatric AR, this product is a novel formulation combining Fluticasone and Azelastine (FA) which is well established in adult and adolescent AR, and has gained popularity in routine clinical practice with perceived benefits. Following its recent approval by the Food and Drug Agency (FDA) for paediatric use, this American study reports a large, randomised, double-blinded, multicenter, placebo-controlled, parallel group, 14-day trial which investigates the efficacy of this drug combination in children with moderate or severe seasonal AR. By employing four different symptom severity scores as the end-point assessments: rTNSS, rTOSS, rT7ss and PRQLQ, it has secondarily elucidated and compared the robustness of these assessment tools within the paediatric population. The treatment regime involves one spray/ nostril bd. Within its intention-to-treat population, each arm features 152 children aged 6 to 11 years and overall, statistical superiority with FA was demonstrated only with PRQLQ score, suggestive of clinically relevant quality of life improvement. No statistical significant difference, however, was observed between treatment and placebo groups using the rTNSS, rTOSS and rT7ss scorings. Interestingly, amongst these assessments, PRQLQ is the only self-reported outcome by children themselves, while the rest contain heterogeneity from children / caregiver rating to different degrees. Rather than a true lack of efficacy with FA the authors have therefore argued the lack of outcome difference may be confounded by the rater assessment bias, particularly from the caregivers scoring which does not necessarily reflect children’s symptoms. The hypothesis was tested with post hoc rater-sensitivity analysis of the endpoints and notably, when child self-rating increases, the statistically significant benefit with FA treatment was increasingly apparent from all scoring tools. Of clinical relevance, the commonest side-effects reported were altered taste sensation and epistaxis. This study represents the first level I evidence for Dymista® use in paediatric AR and furthermore, has highlighted the potential impact of caregiver-reported outcome in children symptoms thus prompting for the development of a robust, reliable and validated paediatric-specific assessment tool for future studies. 

Efficacy of MP-AzeFlu in children with seasonal allergic rhinitis: importance of paediatric symptom assessment.
Berger W, Meltzer EO, Amar N, et al.
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Shiying Hey

MB ChB, DO-HNS, PG Dip ClinEd, FRCS (ORL-HNS), NHS Lothian, UK.

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