A COMPARISON OF THE EFFICACY OF FLUTICASONE PROPIONATE AQUEOUS NASAL SPRAY AND LORATADINE, ALONE AND IN COMBINATION, FOR THE TREATMENT OF SEASONAL ALLERGIC RHINITIS

BACKGROUND. Intranasal corticosteroids and oral antihistamines are bot h effective in the treatment of seasonal allergic rhinitis, although t he therapeutic value of administering the two types of agents concurre ntly has rarely been evaluated. This study was designed to compare the efficacy, safety and impact on quality of life of fluticasone propion ate aqueous nasal spray (FP ANS), loratadine, FP ANS plus loratadine, and placebo (an aqueous nasal spray plus tablet) in the treatment of s easonal allergic rhinitis during the mountain cedar allergy season in south central Texas. METHODS. Six hundred patients with seasonal aller gic rhinitis were treated for 2 weeks with either FP ANS 200 mu g once daily, loratadine 10 mg once daily, the FP ANS and loratadine regimen s combined, or placebo in a multicenter, randomized, double-blind, dou ble-dummy, parallel-group study. RESULTS. Clinician- and patient-rated total and individual nasal symptom scores after 7 and 14 days of ther apy and overall evaluations were significantly lower (P <.001) in the FP ANS and FP ANS plus loratadine groups compared with the loratadine only and placebo groups. Loratadine was not statistically different fr om placebo in clinician and patient symptom score ratings nor in overa ll clinician and patient evaluations. FP ANS plus loratadine and FP AN S monotherapy were comparable in efficacy in almost all evaluations; f or some patient-rated symptoms the combination was found superior. Mea n score changes in the Rhinoconjunctivitis Quality of Life Questionnai re from baseline to day 14 showed significantly greater improvement (P <.001) in quality of life in the FP ANS group than in the group of pa tients receiving loratadine only or placebo, and no significant benefi t was demonstrated in the FP ANS plus loratadine group over the FP ANS monotherapy group. No serious or unusual drug-related adverse events were reported. Combining loratadine with FP ANS did not alter the adve rse events profile or frequency. CONCLUSIONS. In the treatment of seas onal allergic rhinitis, FP ANS is superior to loratadine and placebo, and adding loratadine to FP ANS does not confer meaningful additional benefit.