Clinical Studies of Fluticasone Propionate Aerosol (2nd Report)

Dose Ranging Study in Patients with Perennial Nasal Allergy

Abstract

In patients with perennial nasal allergy, clinical efficacy and safety of FP were evaluated and its optimal dosage was also confirmed, through intergroup comparison among 50,100,200 and 400mcg/day, all with 2 weeks' treatment.
1. In the analysis of final overall improvement, there were significant differences among the four groups (H test, p≤0.05). Cases assessed as markedly improved accounted for 5% in the 50mcg/day group, 19% in the 100mcg/day group, 40% in the 200mcg/day group, and 33% in the 400mcg/day group ; the rates being higher in the high dose groups than in the low dose groups. The rates of markedly improved plus moderately improved cases were as high as above 70%, in the three groups except the 50mcg/day group.
2. Although adverse events were observed in 6 cases out of the total 198 cases assessed, the major symptoms were intranasal irritancy feeling and intranasal pain at the time of dosing, none of which were severe.
Based on the above results, clinical efficacy and safety of FP were established and the 200mcg/day (25mcg×2 shots per nostril, twice daily) was judged as the optimal dose.