Efficacy and safety of fluticasone furoate 100聽渭g once-daily in patients with persistent asthma: A 24-week placebo and active-controlled randomised trial

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• 作者：Jan L枚tvall ; Eugene R. Bleecker ; William W. Busse ; Paul M. O'Byrne ; Ashley Woodcock ; Edward M. Kerwin ; Sally Stone ; Richard Forth ; Loretta Jacques ; Eric D. Bateman
• 关键词：Asthma ; Inhaled corticosteroids ; Once-daily ; Fluticasone furoate
• 刊名：Respiratory Medicine
• 出版年：January, 2014
• 年：2014
• 卷：108
• 期：1
• 页码：41-49
• 全文大小：620 K

文摘

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Summary

Inhaled corticosteroids (ICSs) improve asthma disease control; once-daily ICS administration may have advantages for patients. Our objective was to assess the efficacy and safety of the novel ICS fluticasone furoate (FF) over 24 weeks versus placebo.

This was a 24-week double-blind, double-dummy, placebo- and active-controlled study () of 343 asthma patients (鈮?2 years) not controlled by their current ICS. Patients were randomised (1:1:1) to FF100聽渭g, placebo (both administered once-daily [OD] via ELLIPTA鈩?dry powder inhaler in the evening) or fluticasone propionate (FP) 250聽渭g (administered twice-daily (BD) via DISKUS鈩?ACCUHALER鈩?. Primary endpoint was change from baseline in pre-dose evening forced expiratory volume in 1s (FEV₁) at Week 24; change from baseline in % rescue-free 24-h periods was a powered secondary endpoint. Adverse events (AEs) were assessed.

FF100聽渭g OD and FP250聽渭g BD significantly improved pre-dose evening FEV₁ compared with placebo at Week 24 (+146聽ml [p聽=聽0.009] and +145聽ml [p聽=聽0.011], respectively). Percentage of rescue-free 24-h periods was increased with FF100聽渭g OD (+14.8%) and FP250聽渭g BD (+17.9%) compared to placebo (both p聽<聽0.001). On-treatment AEs were reported by 53% (FF100聽渭g OD), 42% (FP250聽渭g BD) and 40% (placebo) of patients. On-treatment severe asthma exacerbations were lower with FF100聽渭g OD (3%) and FP250聽渭g BD (2%) than placebo (7%). There was significant suppression of urinary cortisol at week 24 with FF100聽渭g OD (p聽=聽0.030) and FP250聽渭g BD (p聽=聽0.036) relative to placebo.

FF100聽渭g OD, administered in the evening, achieves significant improvements in lung function and rescue inhaler use over 24 weeks, comparable to FP250聽渭g BD with similar safety profile.