A double-blind, placebo-controlled comparison of treatment with fluticasone propionate and levocabastine in patients with seasonal allergic rhinitis

Fluticasone propionate aqueous nasal spray (FPANS) is a topically active gl ucocorticoid which has been successfully used for the treatment of seasonal allergic rhinitis (SAR). Topical levocabastine is a highly selective H-1 a ntagonist which has been proposed as an alternative treatment of SAR. The p urpose of this study was to compare the clinical efficacy of two topical na sal treatments, FPANS and levocabastine, in the treatment of SAR, Additiona lly, the effect of treatments on nasal inflammation was examined during nat ural pollen exposure. A group of 288 adolescent and adult patients with at least a 2-year history of SAR to seasonal pollens participated in a multice nter, double-blind, double-dummy, and placebo-controlled study. Patients we re treated with either FPANS 200 mu g, once daily (n=97), or topical levoca bastine, 200 pg, given twice daily (n=96), or matched placebo (n=95) for a period of 6 weeks, starting from the expected beginning of the pollen seaso n. Clinically relevant pollens included Parietaria, olive, and grass. Asses sment of efficacy was based on scores of daily nasal symptoms and on nasal cytology of nasal lavage. Nasal lavage was performed immediately before, du ring, and at the end of treatment in 39 patients. FPANS significantly incre ased the percentage of symptom-free days for nasal obstruction on waking an d during the day, rhinorrhea, sneezing, and itching. FPANS provided a bette r control for night and day nasal obstruction (P<0.02 and P<0.01) and rhino rrhea (P<0.01) than levocabastine. In addition, fewer patients treated with FPANS used rescue medication (P<0.025). The percentage of eosinophils in n asal ravage was reduced only during treatment with FPANS. The results of th is study indicate that FPANS 200 mu g, once daily, provides a better clinic al effect than levocabastine 200 mu g, twice daily, in patients with SAR. U nlike levocabastine, FPANS significantly attenuates nasal eosinophilia duri ng pollen exposure, a feature which may explain its therapeutic efficacy.