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Azelastine hydrochloride nasal spray and its combination with fluticasone propionate in the management of allergic rhinitis - A comparative study

Lalitha A, Mamatha K R, Puttamadaiah G M.


Background: Allergic rhinitis (AR) is a global health problem affecting 500 million of population. H1-antihistamines are the first-line therapy although intranasal corticosteroids are the gold standard treatment in patients with more severe symptoms.

Aims and Objectives: The aim of the study was to evaluate the efficacy and safety of azelastine hydrochloride nasal spray and its combination with fluticasone propionate nasal spray in the management of AR.

Materials and Methods: A total of 70 patients clinically diagnosed as AR were randomized into two groups, Group A received azelastine hydrochloride nasal spray alone and Group B received a combination of azelastine hydrochloride with fluticasone propionate nasal spray for 2-weeks. Efficacy was assessed by mean change in the total symptom score (TSS) which was the sum of total nasal symptom score (TNSS) and total ocular symptom score (TOSS) at the end of 2 weeks from baseline.

Results: Both groups showed statistically significant (P < 0.0001) improvements in the symptoms at the end of 2 weeks of treatment. In Group A, the baseline TNSS, TOSS, and TSS was 9.88 ± 0.99, 5.8 ± 1.32, and 15.68 ± 1.98, respectively, which was reduced to 5.78 ± 2.35, 1.60 ± 1.19, and 5.78 ± 2.35. In Group B, TNSS, TOSS, and TSS were reduced from 9.97 ± 0.92 to 2.71 ± 1.36, 6.08 ± 1.37 to 1.04 ± 0.87, and 16 ± 1.86 to 3.22 ± 1.64, respectively. There was a greater reduction in symptom score in Group B than Group A which was statistically significant (P < 0.0001).

Conclusion: Combination of azelastine hydrochloride with fluticasone propionate nasal spray offers an advantage over the treatment with azelastine hydrochloride alone in regard to symptomatic improvement in AR.

Key words: Allergic Rhinitis; Nasal Sprays; Intranasal; Azelastine Hydrochloride; Fluticasone Propionate

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