Abstract
Fluticasone furoate/vilanterol trifenatate (FF/VI) is a once-daily 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 over 12 weeks.
Moderate to very severe COPD patients received FF/VI 100/25 μg once daily in the morning (n=266) or FP/SAL 500/50 μg twice daily (n=262). The primary end-point was a change from baseline in 0–24 h weighted mean forced expiratory volume in 1 s (wmFEV1) at 12 weeks. Additional end-points included time to 100 mL improvement from baseline on day 1 and a 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 (weighted mean 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 three 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 once daily and FP/SAL 500/50 μg twice daily; there was no apparent difference between the safety profiles of either therapy.
Abstract
Once-daily fluticasone furoate/vilanterol trifenatate and twice-daily fluticasone propionate/salmeterol act similarly http://ow.ly/sdj0x
Footnotes
This article has supplementary material available from www.erj.ersjournals.com
Clinical trial: This study is registered at www.clinicaltrials.gov with identifier number NCT01342913; GlaxoSmithKline Study Code HZC113107.
Support statement: This work was funded by GlaxoSmithKline. Editorial support from G. Weller (Gardiner-Caldwell Communications, Macclesfield, UK) was also funded by GlaxoSmithKline.
Conflict of interest: Disclosures can be found alongside the online version of this article at www.erj.ersjournals.com
- Received March 26, 2013.
- Accepted July 30, 2013.
- ©ERS 2014