A comparison of the efficacy and safety of once-daily fluticasone furoate/vilanterol with twice-daily fluticasone propionate/salmeterol in moderate to very severe COPD

Abstract

Fluticasone furoate/vilanterol trifenatate (FF/VI) is a once-daily (OD) inhaled corticosteroid/long-acting β2-agonist combination in development for chronic obstructive pulmonary disease (COPD) treatment. We compared the efficacy and safety of FF/VI versus fluticasone propionate/salmeterol (FP/SAL) twice-daily (BD) over 12 weeks.

Moderate to very severe COPD patients received FF/VI 100/25 μg OD in the morning (N=266) or FP/SAL 500/50 μg BD (N=262). Primary endpoint: change from baseline in 0–24 h weighted mean forced expiratory volume in 1 s (wmFEV1) at 12 weeks. Additional endpoints included: time to 100 mL improvement from baseline on day 1; change from baseline in St George's Respiratory Questionnaire (SGRQ). Safety was also assessed.

wmFEV1 (mean, 130 mL) was greater and time to 100 mL improvement shorter (median, 16 min) with FF/VI than FP/SAL (mean [wm], 108 mL; median, 28 min). Health status (SGRQ total score) improved in both groups (FF/VI, –4.3 units; FP/SAL, –3.0 units). Differences between treatments were not statistically significant. Six patients in the FF/VI (2%) and 3 in the FP/SAL (1%) arm experienced serious adverse events, none of which were considered to be drug-related.

Improvements in lung function and health status were not significantly different between FF/VI 100/25 μg OD and FP/SAL 500/50 μg BD; there was no apparent differentiation between the safety profiles of either therapy.