Efficacy and Safety of Fluticasone Furoate and Oxymetazoline Nasal Spray: A Novel First Fixed Dose Combination for the Management of Allergic Rhinitis with Nasal Congestion.

ABSTRACT

Objective: To compare the efficacy and safety of a fixed dose combination of Fluticasone Furoate and Oxymetazoline Hydrochloride Nasal Spray 27.5/50 mcg (FDC) with Fluticasone Furoate Nasal Spray 27.5 mcg (Fluticasone) in the management of allergic rhinitis. Patients and Methods: A prospective, randomized, double-blind, two-arm, active-controlled, parallel, multicenter, comparative clinical study was conducted in patients with allergic rhinitis aged 18 years and above having moderate-to-severe nasal congestion. Results: A total of 250 patients were randomized (11) to receive either the FDC or Fluticasone alone in a dose of two sprays in each nostril once daily at night. There was a significantly (P<0.001) greater reduction in night-time Total Nasal Symptom Score with the FDC as compared to Fluticasone at all the time points starting from as early as day 3 and sustained till the end of treatment (Day 28) (Day 3 -3.1 vs -2.2; Day 7 -4.0 vs -3.4; Day 14 -5.7 vs -5.0; Day 28 -7.0 vs -6.4). A significantly greater number of patients (P<0.05) had complete relief in Nasal Congestion with the FDC (44.7%) as compared to Fluticasone (26.8%). Both the study medications were well tolerated by all the patients. The proportion of patients showing worsening of symptoms (rebound congestion/rhinitis medicamentosa) after stoppage of medication was similar in both groups (P>0.05). Conclusion: The FDC was superior to Fluticasone alone in relieving the nasal congestion and reduction of Total Nasal Symptom Score in allergic rhinitis patients with moderate-to-severe nasal congestion when administered once daily in the evening. Oxymetazoline when used along with the nasal steroid in a once daily dose does not cause rebound congestion and rhinitis medicamentosa even after long-term continuous use of 28 days.