Intranasal Fluticasone Once Daily Compared with Once-Daily Cetirizine in the Treatment of Seasonal Allergic Rhinitis : Results of a Multicentre, Double-Blind Study.

The efficacy and tolerability of fluticasone aqueous nasal spray, 200µg once daily for 21 days, was compared with cetirizine, 10mg once daily for 21 days, in a multicentre, randomised, double-blind, double-dummy, parallel group study. 237 evaluable patients aged 12 years and above, with seasonal allergic rhinitis (defined as having a positive skin test and a total symptom score of ≥ 6/15), received either fluticasone aqueous nasal spray (n = 119) or cetirizine (n = 118). Improvement in total symptom score was observed in patients from both treatment groups, with the improvement in the fluticasone treatment group being significantly greater (decrease in total symptom score from 9.23 to 2.13) than in the cetirizine treatment group (decrease in total symptom score from 9.36 to 4.31; p < 0.001). There was also a significantly greater improvement in the number of symptom-free days for all symptoms in favour of fluticasone aqueous nasal spray compared with cetirizine (p < 0.001). Furthermore, the percentage of days when patients did not require terfenadine as rescue therapy was significantly greater in the fluticasone group (87%) than in the cetirizine group (80%; p < 0.05). Five adverse events were reported during intranasal fluticasone treatment and 10 adverse events were reported during cetirizine therapy. There were no treatment-related withdrawals from therapy in the fluticasone group, but 5 treatment-related withdrawals were reported in the cetirizine group.This study demonstrated that fluticasone aqueous nasal spray, 200µg once daily, was significantly more effective than cetirizine, 10mg once daily, and had comparable (if not better) tolerability, in the treatment of seasonal allergic rhinitis.

RCT Entities:   Population Interventions Outcomes