Comparative study of the efficacy and safety of intranasal azelastine hydrochloride and fluticasone furoate in the treatment of allergic rhinitis.

Background: Allergic rhinitis (AR) is characterized by nasal itch, sneezing, watery or mucous rhinorrhea, nasal obstruction, and nasal or pharyngeal irritation. If untreated, AR can impair patients' quality of life (QOL). Azelastine hydrochloride (AH), histamine receptor antagonists, has anti-inflammatory and mast cell stabilizing properties. Fluticasone furoate (FF) is an anti-inflammatory agent with action on mast cells, eosinophils, neutrophils, macrophages, and lymphocytes. This study compares the efficacy and safety of these medications in AR.

Materials and methods: Patients in the study had been clinically diagnosed with AR. In each group, there were 75 randomized patients who were to receive either FF (27.5 μg/spray) or AH (0.10%) intranasally twice daily. Assessment in terms of symptoms (total nasal symptom score), signs (endoscopic staging), QOL, eosinophil count, and sensory attributes was done at baseline, day 7, and day 15. Adverse effects were recorded, and the cost incurred was analyzed. Paired and umpaired t-test were used to compare symptom scores, QOL scores, and absolute eosinophil count within and between the groups, respectively.

Results: The total number of patients was 150 (76 males and 74 females); the mean age for FF group was 26.23 ± 5.2 years, and 26.96 ± 4.8 years for AH group. By day 7, there was a reduction of all scores in both medications, but the reduction in reduction was highly significant with FF (P = 0.001). There was a significant reduction (P = 0.001) in absolute eosinophil count both in blood and nasal smears by day 15 in both the groups; the reduction was significant (P = 0.001) with fluticasone. Adverse reactions were reported by 33.3% of patients receiving FF and 28% patients receiving AH.

Conclusion: Fluticasone furoate produced sustained relief of symptoms, signs, and sensory attributes with a greater reduction in eosinophil count in comparison with AH in patients with allergic rhinitis.