July 21, 2014

Efficacy and safety of fluticasone furoate 100 mug and 200 mug once daily in the treatment of moderate-severe #asthma in adults and adolescents: a 24-week randomised study

Research article

Ashley WoodcockJan LötvallWilliam W BusseEric D BatemanSally StoneAnna Ellsworth and Loretta Jacques

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BMC Pulmonary Medicine 2014, 14:113  doi:10.1186/1471-2466-14-113
Published: 9 July 2014

Abstract (provisional)

Background

Inhaled corticosteroids are a mainstay of therapy for persistent asthma, but suboptimal adherence with twice-daily use is widespread. Fluticasone furoate (FF) is a new inhaled corticosteroid (ICS) suitable for once-daily dosing in asthma. This study was performed to descriptively assess the efficacy and safety of two doses of FF, with no planned formal statistical hypothesis testing.

Methods

This was a 24-week double-blind, multicentre, parallel-group study (NCT01431950). Patients aged >=12 years with moderate-severe persistent asthma and uncontrolled on mid-high dose ICS were stratified by baseline FEV1 and randomised (1:1) to treatment with FF 100mug or 200mug once daily in the evening. The primary endpoint was change from baseline trough FEV1 after 24 weeks; secondary and other endpoints included peak expiratory flow (PEF) and rescue- and symptom-free 24-hour periods over Weeks 1-24, and Asthma Control TestTM (ACT) score at Week 24. A pre-specified subgroup analysis of patients by randomisation strata was performed for the primary and selected secondary and other endpoints. Safety assessments included adverse events, laboratory and vital sign measurements, and change from baseline in 24-hour urinary cortisol at Week 24.

Results

With FF 100mug and 200mug, least squares mean trough FEV1 improved from baseline by 208mL and 284mL respectively at Week 24; treatment difference: 77mL (95% CI: -39, 192). Similar improvements from baseline in rescue- and symptom-free periods, and morning and evening PEF were observed in both groups. Patients were 42% more likely to be well-controlled (ACT score >=20) with FF 200mug than with FF 100mug. Slightly more patients receiving FF 200mug vs. FF 100mug reported adverse events (63% vs. 59%) and events deemed treatment related (5% vs. -1%). Seven serious adverse events (FF 200mug 4; FF 100mug 3) were reported, none of which were deemed treatment related. No clinically relevant effects of either dose on 24-hour urinary cortisol were observed.

Conclusion

Improvements from baseline in trough FEV1 were observed after 24 weeks of treatment with both doses of FF, with a numerically greater improvement in FEV1 observed in patients receiving FF 200mug. Secondary endpoint findings were similar between groups. No safety concerns were identified during the study.

The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.

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