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news.GlaxoSmithKline and Theravance, a biopharmaceutical company, have announced positive results from three, separate Phase IIb studies assessing efficacy and safety of GSK's inhaled corticosteroid fluticasone furoate across a range of eight doses in over 1,800 patients with mild, moderate and severe asthma.
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Once-daily fluticasone furoate (FF) produced statistically significant improvements in patients’ lung function (trough FEV1) compared to placebo (p < 0.05) in each of the three study populations and at all doses, with the exception of the very lowest dose tested. In all studies numerically greater improvements in lung function were observed with a lower total daily dose of FF compared to fluticasone proprionate (FP), the two companies said.
The three dose-ranging studies fully characterized FF’s dose response curve, with only the lowest dose (25mcg) showing no statistically significant difference from placebo on the primary efficacy endpoint (trough FEV1) and with only the highest dose (800mcg) associated with a statistically significant reduction in urinary cortisol levels. FF was well tolerated throughout the course of the eight-week treatment period across the three studies.
Darrell Baker, senior vice president of respiratory medicines development centre at GlaxoSmithKline (GSK), said: The strong results from these three studies demonstrate that fluticasone furoate shows promise as an efficacious, once-daily inhaled corticosteroid. Additionally, the consistent responses seen demonstrate the robust nature of these data.