A DOUBLE-BLIND COMPARISON OF FLUTICASONE PROPIONATE AQUEOUS NASAL SPRAY, TERFENADINE TABLETS AND PLACEBO IN THE TREATMENT OF PATIENTS WITH SEASONAL ALLERGIC RHINITIS TO GRASS-POLLEN

Fluticasone Propionate Aqueous Nasal Spray (FPANS) contains a topicall y active glucocorticoid fluticasone propionate which has been used suc cessfully for the treatment of seasonal allergic rhinitis. This multic entre, randomized, double-blind, double-dummy, placebo-controlled, par allel group study was designed to compare the efficacy and tolerabilit y of FPANS with terfenadine tablets or placebo in controlling the symp toms of allergic rhinitis to grass pollen. Two hundred and fourteen pa tients were treated for 6 weeks during the grass pollen season with ei ther FPANS 200 mu g once daily, terfenadine tablets (60 mg) twice dail y or placebo. Efficacy was evaluated by the analysis of symptom-free d ays and median symptom scores. Patients receiving FPANS had significan tly more days free of nasal blockage on waking (P = 0.012) and during the day (P = 0.01) and of rhinorrhoea (P = 0.027) than those receiving terfenadine. Additionally, in terms of absolute efficacy, patients re ceiving FPANS demonstrated significantly more days free of the above s ymptoms (P = 0.017, P = 0.028, P = 0.004, respectively) and of sneezin g (P < 0.001) than those receiving placebo. There were no significant differences in symptoms of nasal itching, eye symptoms, of symptoms of drowsiness between the three treatment groups. Patients in the FPANS group had significantly lower median symptom scores for nasal blockage on waking (P < 0.001) and during the day (P < 0.018) than those in th e terfenadine group and significantly lower scores for nasal blockage on waking (P < 0.001), sneezing (P < 0.013) and rhinorrhoea (P = 0.005 ) than those in the placebo group. The use of rescue medication was si milar in all three treatment groups. Adverse events were similar in na ture and frequency in all three treatment groups, most were mild and c onsidered by the investigator at each centre unlikely to be related or unrelated to the study treatment. There were very few clinically sign ificant laboratory abnormalities observed in any group. It is conclude d that FPANS (200 mu g once daily) is an effective and well-tolerated treatment for seasonal allergic rhinitis and is significantly more eff ective than terfenadine (60 mg twice daily) in controlling nasal block age at all times of the day and rhinorrhoea.