Clinical studies of Fluticasone Propionate Aqueous Nasal Spray (4th report)

Study of long term administration in perennial allergic rhinitis

Abstract

To evaluate its clinical efficacy and safety, Fluticasone Propionate (FP) Aqueous Nasal Spray was administered to 83 patients with perennial allergic rhinitis in the dose of either 200mcg/day (68 patients) or 400mcg/day (15 patients) for a long term of at least 4 weeks in principle (One received for 22 weeks). The following results were found. 1. In the assessment of final overall improvement, cases assessed as “markedly improved” or “moderately improved” accounted for a high rate of about 90%, and in almost all cases, at least a “slight improvement” was observed. In those cases in which maintenance of efficacy could be assessed, even 1 week after completion of treatment, efficacy was observed to be sustained in about 70%. 2. An adverse event occurred in 1 case and abnormalities in clinical laboratory test values were observed in 3 cases. However, they were all clinically insignificant and the incidence rate was not observed to increase in relation to the duration of the treatment period. Based on the above results, FP Aqueous Nasal Spray was confirmed as a drug with superior clinical efficacy, and judged as safe even when used for long term treatment.