Azelastine‐fluticasone intranasal therapy: A paradigm shift in pediatric allergic rhinitis management. A point of view of the Italian Society of Pediatric Allergy and Immunology

Background: Allergic rhinitis (AR) is one of the most prevalent chronic conditions in children and adolescents, significantly impacting quality of life and scholastic performance. Effective management requires therapeutic approaches that address the complex pathophysiology while ensuring safety and tolerability. Methods: This paper reviews the evidence supporting azelastine-fluticasone combination intranasal therapy in pediatric allergic rhinitis, with a focus on efficacy, safety, and clinical implementation. This paper encompassed clinical trials, guidelines (ARIA), consensus statements (SIAIP Delphi Consensus), and real-world evidence gathered from Italian primary care pediatricians managing children and adolescents with AR. Results: Azelastine-fluticasone combination therapy demonstrates superior efficacy compared to monotherapy, exhibiting a rapid onset of action (15–30 min) and sustained symptom control. Its dual mechanism effectively addresses both early-phase (H1-receptor antagonism) and late-phase (glucocorticoid anti-inflammatory effects) allergic responses. Clinical trials conducted in adolescents aged 12–18 years confirm an excellent safety profile, with no significant effects observed on growth or the Hypothalamic–Pituitary–Adrenal (HPA) axis. Emerging evidence further may support its potential utility in younger children aged 6–12 years. The SIAIP Delphi Consensus on AR management, involving 42 pediatricians, achieved over 80% agreement on key management principles, particularly emphasizing the control of type 2 inflammation. Survey data collected from 864 Italian primary care pediatricians, collectively managing 81,231 children, indicates high adherence to ARIA guidelines (exceeding 70%) and a notable increase in the adoption of combination therapy, reaching up to 20% of cases. Conclusion: Azelastine-fluticasone combination intranasal therapy represents a significant paradigm shift in pediatric allergic rhinitis management. It offers superior efficacy, an excellent safety profile, and practical advantages that foster better treatment adherence. This therapeutic approach is well-aligned with contemporary guidelines and is increasingly being adopted in clinical practice for the management of moderate to severe AR in children and adolescents.