Efficacy Analysis of MP-AzeFlu Compared with Fluticasone Propionate Nasal Spray in Children 6 through 11 Years of Age with Allergic Rhinitis

Abstract

MP-AzeFlu (Dymista®) is a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP) for treatment of allergic rhinitis. The objective of the current analysis was to evaluate the efficacy of MP-AzeFlu compared to FP administered 1 spray per nostril twice daily in children 6 through 11 years of age. This was a randomized, open-label, 3-month safety study in patients 4 through 11 years of age. Qualified patients had a history of AR, were in good health, and had no evidence of nasal mucosal erosion, nasal ulceration, nasal septum perforation, or any significant nasal disease. Randomization was in a 3:1 ratio (MP-AzeFlu [n=304]:FP [n=101]). Efficacy was not a pre-specified study objective but was evaluated by self-assessment of overall allergy symptom severity in a subset of patients 6 through 11 years (MP-AzeFlu [n=264]:[FP: n=89]). Symptom severity was scored on a 4-point scale from 0 to 3 (0 = none; 1 = mild; 2 = moderate; 3 = severe). Total symptom score at baseline was 1.73 in the MP-AzeFlu group and 1.80 in the FP group (max score: 3). Over the entire study period, patients treated with MP-AzeFlu experienced a -0.68 pt reduction in overall symptom score (corresponding to a -5.44 change from baseline in AM + PM reflective total nasal symptom score (rTNSS; max = 24), significantly greater relief than that afforded by FP (-0.54 pt reduction; Diff: -0.14; 95% CI: -0.28, -0.01; p=0.04). MP-AzeFlu provided significantly greater relief of AR symptoms than FP in children 6 through 11 years of age.