Fluticasone furoate / Vilanterol ( FF/VI; Relvar Ellipta ) is an inhaled corticosteroid / long-acting beta2-agonist ( ICS / LABA ), recently approved as once-daily maintenance therapy for COPD.
Researchers have compared the lung function effects of Fluticasone furoate / Vilanterol with those of twice-daily Fluticasone propionate / Salmeterol ( FP/SAL; Advair ).
Three 12 week studies comparing FF/VI and FP/SAL were conducted. Patients aged 40 years or more with moderate-to-very severe COPD were randomized to receive double-blind, double-dummy FF/VI 100/25 mcg once-daily, or FP/SAL 250/50 mcg twice-daily for 12 weeks following a 2 week placebo run-in period.
The primary endpoint of each study was change from baseline trough in 0–24 h weighted mean FEV1 ( wmFEV1 ) on Day 84. Safety was also assessed.
In Study 1 ( HZC113109 ) ( intent-to-treat n: FF/VI = 260; FP/SAL = 259 ), the increase from baseline in 0–24 h wmFEV1 was significantly greater with FF/VI than FP/SAL ( Δ80 mL, P less than 0.001 ).
In Study 2 ( HZC112352 ) ( intent-to-treat n: FF/VI = 259; FP/SAL = 252 ) and Study 3 ( RLV116974 ) ( intent-to-treat n: FF/VI = 412; FP/SAL = 416 ), the increase from baseline in 0–24 h wmFEV1 was not significantly greater with FF/VI than FP/SAL ( Δ29 mL, P = 0.267; Δ25 mL, P = 0.137 ).
The treatment difference was statistically but not clinically significant in a pooled analysis ( Δ41 mL, P < 0.001 ).
Pooled adverse events ( FF/VI 27%; FP/SAL 28% ) and serious adverse events ( FF/VI 2%; FP/SAL 3% ) were similar between treatments.
In conclusion, the data suggest that once-daily Fluticasone furoate / Vilanterol 100/25 mcg provides FEV1 improvement in COPD that is at least comparable with that conferred by twice-daily Fluticasone propionate / Salmeterol 250/50 mcg, although interpretation is limited by differences in individual study outcomes.
The safety profiles of Fluticasone furoate / Vilanterol 100/25 mcg and Fluticasone propionate / Salmeterol 250/50 mcg are similar. ( Xagena )
Dransfield MT et al, Respir Med 2014; Epub ahead of print