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




Ethnic sensitivity assessment of fluticasone furoate-vilanterol in East Asian asthma patients from randomized double-blind multicentre Phase IIb-III trials - Download this document for free, or read online. Document in PDF available to download.

BMC Pulmonary Medicine

, 15:165

First Online: 24 December 2015Received: 29 June 2015Accepted: 14 December 2015

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.

Keywordsβ2-adrenergic receptor agonists Asthma Glucocorticoids Japan Treatment outcome AbbreviationsAEAdverse event

ANCOVAAnalysis of covariance

BDTwice daily

CIConfidence interval

DPIDry powder inhaler

ECGElectrocardiogram

FEV1Forced expiratory volume in one second

FFFluticasone furoate

FPFluticasone propionate

HPAHypothalamic-pituitary-adrenal

ICSInhaled corticosteroid

ITTIntent-to-treat

LABALong-acting β2-agonist

LSLeast-squares

minMinimum

maxMaximum

ODOnce daily

QTcFQT corrected using Frederica’s correction

SAESerious adverse event

SDStandard deviation

SEStandard error

VIVilanterol

Electronic supplementary materialThe online version of this article doi:10.1186-s12890-015-0159-z contains supplementary material, which is available to authorized users.

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Author: Annette S. Gross - Caroline Goldfrad - Soichiro Hozawa - Mark H. James - Christine S. Clifton - Yutaro Sugiyama - Loretta

Source: https://link.springer.com/article/10.1186/s12890-015-0159-z







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