Comparison of the effects of fluticasone propionate, aqueous nasal spray and levocabastine on inflammatory cells in nasal lavage and clinical activity during the pollen season in seasonal rhinitis

Background Treatment options for allergic rhinitis include antihistamines, decongestants, anticholinergics, cromolyn sodium and corticosteroids. As th e nose is a small organ, comprising less than 1% of total body mass and sur face area, it seems logical to confine treatment of rhinitis to the disease d organ. Objective To evaluate the effects of therapy with intranasal fluticasone pr opionate (FP), both on subjective symptoms and pathophysiological mechanism s, in rhinitis patients during pollen season when the patients were symptom atic. Methods We used a double-blind, placebo (PLA)-controlled, randomized, doubl e dummy, parallel group study of the effect of 6 weeks treatment. The doubl e-blind comparison was made between the following three treatments: FP aque ous nasal spray, 200 mu g taken once daily, levocabastine (LEV) nasal spray , 200 mu g taken twice daily and PLA nasal spray. Clinical evaluation and t he levels of cells and mediators in nasal washing were performed before and after treatments. Twenty-four patients (11 men and 13 women, aged 17-50 ye ars, mean age 30.1 +/- 8.5) with strictly seasonal allergic rhinitis to Par ietaria entered the study. Clinical evaluation and the levels of inflammato ry cells (eosinophils and activated eosinophils, i.e. EG(2)(+)) and their m ediators (tryptase, eosinophil cationic protein, eosinophil protein X and n eutrophil myeloperoxidase) in nasal-lavage were performed before and after treatments. Results Treatment with FP significantly increased, with respect to placebo, the percentage of days without sneezing (P<0.001), nasal blockage (P<0.001 ), rhinorrhea (P<0.001), nasal itching (P<0.001). Furthermore, treatment wi th FP showed additional benefits with respect to LEV. The percentage of day s without nasal blockage was significantly higher in the FP group that in t he placebo group (P=0.018). The same applied to rhinorrhea (P=0.009). The p ercentages of days without sneezing and itching were instead not significan tly different between the two groups. As expected, no significant differenc es were observed in baseline medians of the rhinitis symptom scores as well as in mean values of all mediators and eosinophils in nasal lavages of the various groups under study. After treatment the mean of subjective symptom s as well as all values in nasal lavage level fell significantly only in th e FP group, whereas no significant changes were observed either in LEV or P LA groups. Accordingly, significant differences were observed at the end of the treatments between the values of fluticasone group vs LEV and PLA grou p values. Significant correlations between these values and symptom scores were found, according with Literature data suggesting a pathogenetic role f or these mediators and eosinophils in rhinitis. Conclusion FP (200 mu g once daily) affords a significant degree of improve ment in rhinitis control during pollen season, as measured by subjective an d objective parameters, compared with LEV (200 mu g twice daily) and PLA. T he therapeutic benefits of intranasal FP are reflected in, and may be cause d by, the decrease in nasal inflammatory cells.