Intranasal Sprays Compared for Allergic Rhinitis in Young Children

Enrolled children were randomized 3:1 to the MP-AzeFlu or fluticasone propionate
Enrolled children were randomized 3:1 to the MP-AzeFlu or fluticasone propionate

ATLANTA, GA—Ellen R. Sher, MD, FAAAAI, from the Atlantic Allergy, Asthma, and Immunology Associates, in Ocean, NJ, presented that MP-AzeFlu (Dymista) provided significantly greater relief of allergic rhinitis symptoms than fluticasone propionate in children aged 6 to <12 years, at the 2017 AAAAI Annual Meeting. 

MP-Azeflu is a new intranasal formulation of azelastine HCl and fluticasone propionate for the treatment of allergic rhinitis. Dr. Sher and coauthor, William E. Berger, MD, MBA, aimed to evaluate the efficacy of MP-AzeFlu vs. fluticasone propionate given as 1 spray per nostril twice daily in children aged 6 to <12 years. 

The randomized, open-label, 3-month study was conducted in children aged 4 to <12 years who had no evidence of nasal mucosal erosion, nasal ulceration, nasal septum perforation, or any significant nasal disease. The enrolled children were randomized 3:1 to the MP-AzeFlu (n=304) or fluticasone propionate (n=101). Each patient received 1 spray in each nostril twice daily, administered approximately 12 hours apart. Efficacy was evaluated by self-assessment of overall allergy symptom severity in the subset of patients aged 6 to <12 years. Symptom severity was graded daily using a 4-point scale where 0 indicated none, 1 indicated mild, 2 indicated moderate, and 3 indicated severe. 

At baseline, the total symptom score was 1.73 in the MP-AzeFlu group and 1.80 in the fluticasone propionate group. During the study period, patients in the MP-AzeFlu group had a -0.68 point reduction in overall symptom score, which was associated with a -5.44 change from baseline in morning and evening reflective total nasal symptom score (rTNSS; max=24). Also, patients in the MP-AzeFlu group experienced significantly greater relief vs. patients in the fluticasone propionate (-0.54 reduction; difference -0.14, 95% CI: -0.28, -0.01; P=0.041). 

The study authors also noted that a difference of 1.12 points on the morning and evening rTNSS scale was observed between the two treatment groups. Additionally, Dr. Sher reported that "superiority of MP-AzeFlu over FP was noted from the first day of assessment and sustained for the 90-day study period."

Dr. Sher concluded that the use of the novel combination spray, MP-AzeFlu, led to greater improvement in allergic rhinitis symptoms than fluticasone propionate in children aged 6–11 years.