Efficacy of Azelastine HCl/Fluticasone Propionate Nasal Spray in the Treatment of Nasal Congestion in Patients with Seasonal Allergic Rhinitis (SAR)

RationaleThe objective of this analysis was to evaluate the efficacy of azelastine/fluticasone propionate (AZ/FP) nasal spray (Dymista) in the treatment of nasal congestion in patients with SAR.MethodsThis evaluation included four, 2-week, double-blind, placebo- and active-controlled studies (studies 4001, 4002, 4004, and 4006) analyzed individually and as a pooled data set. AZ/FP was compared to monotherapy with AZ and FP and to placebo. All treatments were administered 1 spray per nostril twice daily (AM and PM). Total daily doses of AZ and FP were 548 mcg and 200 mcg, respectively. The primary efficacy variable was change from baseline in the 12-hour reflective total nasal symptom score (rTNSS), which included nasal congestion, sneezing, itchy nose, and runny nose scored twice daily (AM and PM) on a 4-point rating scale such that the maximum daily score was 24.ResultsAZ/FP was statistically superior (P