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ARTICLE | Clinical News

Intranasal fluticasone propionate: Phase II data

August 16, 2010 7:00 AM UTC

A post hoc subgroup analysis of a double-blind Phase II trial in 109 patients showed that twice-daily intranasal fluticasone significantly reduced polyp size in patients with baseline summed polyp scores of 2, 3 and 4 at weeks 8 and 12 vs. placebo (p<0.033 for all), but not at week 4. Larger polyps result in a higher summed polyp score on the Lildholdt scale, which has a maximum score of 4.

In patients with a baseline summed polyp score of 4 (n=31), intranasal fluticasone significantly reduced mean polyp size by 42% from baseline to week 12 vs. placebo (p=0.0001). In patients with a baseline summed polyp score of 3 (n=24), intranasal fluticasone significantly reduced mean polyp size by 33% from baseline to week 12 vs. placebo (p=0.0011). In patients with a baseline summed polyp score of 2 (n=54), intranasal fluticasone significantly reduced mean polyp size by 28% from baseline to week 12 vs. placebo (p=0.007), and 26% of patients treated with intranasal fluticasone had completely resolved polyps on both sides of the nasal cavity. Furthermore, previous sinus surgery had no impact on efficacy, with both surgical and non-surgical subgroups experiencing about a 35% reduction in polyp size. Data were published in the American Journal of Rhinology and Allergy. ...