Ethnic sensitivity assessment of fluticasone furoate/vilanterol in East Asian asthma patients from randomized double-blind multicentre Phase IIb/III trials

Abstract

BackgroundFluticasone furoate (FF)/vilanterol (VI) is a once daily (OD) inhaled corticosteroid/long-acting β2-agonist combination asthma therapy approved in Japan and the EU. FF/VI efficacy and safety data from asthma studies including patients in East Asia were evaluated to assess ethnic sensitivity.MethodsRandomized, double-blind, multicenter Phase IIb/III trials were assessed. Change from baseline relative to placebo or twice-daily fluticasone propionate 500 μg in trough FEV1 was compared between patients from Japan (N = 148) and Not-Japan (N = 3,066; three studies). Adverse events (AEs), laboratory results, and electrocardiograms were compared between patients from Japan + Korea (N = 188) and Not-Japan + Korea (N = 3,840; five studies).ResultsFor trough FEV1, improvements from baseline (least-squares mean difference [95 % confidence interval]) were reported for FF/VI 100/25 μg OD versus placebo at Week 12 (Japan: 0.323 L [0.104–0.542]; Not-Japan: 0.168 L [0.095–0.241]). Improvements from baseline (least-squares mean change [standard error]) were reported with FF/VI 200/25 μg OD at Week 24 (Japan: 0.355 L [0.1152]; Not-Japan: 0.396 L [0.0313]). A greater proportion of patients from Japan + Korea versus Not-Japan + Korea reported AEs in all treatment arms including placebo (FF/VI 100/25 μg: 79 % versus 57 %; FF/VI 200/25 μg: 64 % versus 45 %; placebo: 41 % versus 23 %). There were no notable differences in treatment-related or class-related AEs. No clinically significant changes in electrocardiogram assessments or statistically significant differences in 24 h urinary cortisol excretion were observed between the Japan + Korea and Not-Japan + Korea cohorts.ConclusionsGood efficacy and an acceptable safety profile were observed for FF/VI 100/25 μg and 200/25 μg OD in East Asian asthma patients; these globally recommended doses are appropriate for asthma patients in Japan.Trial registrationClinicaltrials.gov registration numbers: NCT01165138, NCT01134042, NCT01086384, NCT00603278, NCT00603382.Electronic supplementary materialThe online version of this article (doi:10.1186/s12890-015-0159-z) contains supplementary material, which is available to authorized users.

Efficacy and safety comparison: Fluticasone furoate and fluticasone propionate, after step down from fluticasone furoate/vilanterol in Japanese patients with well-controlled asthma, a randomized trial

“…Additionally, as the study was conducted entirely in Japan, the applicability of the results to other ethnicities remains to be determined. However, recent publications have suggested that the efficacy and safety of both FF/VI OD (and FF OD) and FP/SAL BD (and FP BD) are of low ethnic sensitivity [28,29].…”

Spotlight on fluticasone furoate/vilanterol trifenatate for the once-daily treatment of asthma: design, development and place in therapy

“…When East Asian patients were compared to non-East Asian patients from the large randomized, double-blind, multicenter clinical trials in a prespecified subgroup analysis, both FF (100 or 200 μg)/VI (25 μg) dose combinations were as effective in improving FEV 1 compared to placebo as in non-East Asian patients 44. A systematic review with meta-analysis of seven published trials (N=5,668) evaluating inhaled FF/VI in asthmatic patients was recently performed 45.…”