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

References

• Asthma GINA Guidelines [homepage on the Internet]Pocket Guide for Asthma Management and Prevention2016 Available from: www.ginasthma.orgAccessed September 1, 2016
   Google Scholar
• US FDA [database on the Internet]2016 Available from: https://www.accessdata.fda.gov/scripts/cder/drugsatfda/Accessed September 1, 2016
   Google Scholar
• CastleWFullerRHallJPalmerJSerevent nationwide surveillance study: comparison of salmeterol with salbutamol in asthmatic patients who require regular bronchodilator treatmentBMJ19933066884103410378098238
   PubMed Web of Science ®Google Scholar
• NelsonHSWeissSTBleeckerERYanceySWDorinskyPMGroupSSThe Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterolChest20061291152616424409
   PubMed Web of Science ®Google Scholar
• PetersSPBleeckerERCanonicaGWSerious asthma events with budesonide plus formoterol vs. budesonide aloneN Engl J Med2016375985086027579635
   PubMed Web of Science ®Google Scholar
• StempelDARaphiouIHKralKMSerious asthma events with fluticasone plus salmeterol versus fluticasone aloneN Engl J Med2016374191822183026949137
   PubMed Web of Science ®Google Scholar
• StempelDASzeflerSJPedersenSSafety of adding salmeterol to fluticasone propionate in children with asthmaN Engl J Med2016375984084927579634
   PubMed Web of Science ®Google Scholar
• BushAFreyUSafety of long-acting beta-agonists in children with asthmaN Engl J Med2016375988989127579641
   PubMed Web of Science ®Google Scholar
• SyedYYFluticasone furoate/vilanterol: a review of its use in patients with asthmaDrugs201575440741825648266
   PubMed Web of Science ®Google Scholar
• AllenABareillePJRousellVMFluticasone furoate, a novel inhaled corticosteroid, demonstrates prolonged lung absorption kinetics in man compared with inhaled fluticasone propionateClin Pharmacokinet2013521374223184737
   PubMed Web of Science ®Google Scholar
• WoodcockABatemanEDBusseWWEfficacy in asthma of once-daily treatment with fluticasone furoate: a randomized, placebo-controlled trialRespir Res20111213221977941
   PubMed Web of Science ®Google Scholar
• KempsfordRDBalJBainesARenauxJRavindranathRThomasPSThe efficacy of fluticasone furoate administered in the morning or evening is comparable in patients with persistent asthmaRespir Med2016112182426823210
   PubMed Web of Science ®Google Scholar
• WoodcockALotvallJBusseWWEfficacy and safety of fluticasone furoate 100 mug and 200 mug once daily in the treatment of moderate-severe asthma in adults and adolescents: a 24-week randomised studyBMC Pulm Med20141411325007865
   PubMed Web of Science ®Google Scholar
• LeeLAYangSKerwinETrivediREdwardsLDPascoeSThe effect of fluticasone furoate/umeclidinium in adult patients with asthma: a randomized, dose-ranging studyRespir Med20151091546225452139
   PubMed Web of Science ®Google Scholar
• YangSLeeLMallettSAyerJWolstenholmeAPascoeSA randomized, crossover study to investigate the pharmacokinetics and safety of inhaled fluticasone furoate and umeclidinium, administered separately and in combination via dry powder inhaler in healthy adult volunteersAdv Ther201532215717125700806
   PubMed Web of Science ®Google Scholar
• ApariciMGavaldaARamosIIn vitro and in vivo preclinical profile of abediterol (LAS100977), an inhaled long-acting beta2-adrenoceptor agonist, compared with indacaterol, olodaterol and vilanterolEur J Pharmacol2016770616926656755
   PubMed Web of Science ®Google Scholar
• KempsfordRNorrisVSiedererSVilanterol trifenatate, a novel inhaled long-acting beta2 adrenoceptor agonist, is well tolerated in healthy subjects and demonstrates prolonged bronchodilation in subjects with asthma and COPDPulm Pharmacol Ther201326225626423232038
   PubMed Web of Science ®Google Scholar
• LötvallJBatemanEDBleeckerER24-h duration of the novel LABA vilanterol trifenatate in asthma patients treated with inhaled corticosteroidsEur Respir J201240357057922362859
   PubMed Web of Science ®Google Scholar
• SterlingRLimJFrithLSnowiseNGJacquesLHaumannBEfficacy and optimal dosing interval of the long-acting beta(2) agonist, vilanterol, in persistent asthma: a randomised trialRespir Med201210681110111522520084
   PubMed Web of Science ®Google Scholar
• OliverAJCovarRAGoldfradCHRandomised trial of once-daily vilanterol in children with asthma on inhaled corticosteroid therapyRespir Res2016173727044326
   PubMed Web of Science ®Google Scholar
• LötvallJBatemanEDBusseWWComparison of vilanterol, a novel long-acting beta2 agonist, with placebo and a salmeterol reference arm in asthma uncontrolled by inhaled corticosteroidsJ Negat Results Biomed2014131924928338
   PubMedGoogle Scholar
• ChenXZhengXJiangJPharmacodynamics and pharmacokinetics of fluticasone furoate/vilanterol in healthy Chinese subjectsPharmacotherapy201535658659926059225
   PubMed Web of Science ®Google Scholar
• NakaharaNWakamatsuAKempsfordRThe safety, pharmacokinetics and pharmacodynamics of a combination of fluticasone furoate and vilanterol in healthy Japanese subjectsInt J Clin Pharmacol Ther201351866067123735179
   PubMed Web of Science ®Google Scholar
• KempsfordRAllenABalJRubinDTombsLThe effect of ketoconazole on the pharmacokinetics and pharmacodynamics of inhaled fluticasone furoate and vilanterol trifenatate in healthy subjectsBr J Clin Pharmacol20137561478148723116485
   PubMed Web of Science ®Google Scholar
• AllenADavisAHardesKTombsLKempsfordRInfluence of renal and hepatic impairment on the pharmacokinetic and pharmacodynamic properties and tolerability of fluticasone furoate and vilanterol in combinationClin Ther201234122316233223200625
   PubMed Web of Science ®Google Scholar
• OliverABjermerLQuinnDModulation of allergen-induced bronchoconstriction by fluticasone furoate and vilanterol alone or in combinationAllergy20136891136114223924233
   PubMed Web of Science ®Google Scholar
• HughesSCShardlowPCHollisFJMetabolism and disposition of fluticasone furoate, an enhanced-affinity glucocorticoid, in humansDrug Metab Dispos200836112337234418694910
   PubMed Web of Science ®Google Scholar
• HarrellAWSiedererSKBalJMetabolism and disposition of vilanterol, a long-acting beta(2)-adrenoceptor agonist for inhalation use in humansDrug Metab Dispos20134118910023043183
   PubMed Web of Science ®Google Scholar
• BernsteinDIBatemanEDWoodcockAFluticasone furoate (FF)/vilanterol (100/25 mcg or 200/25 mcg) or FF (100 mcg) in persistent asthmaJ Asthma201552101073108326291137
   PubMed Web of Science ®Google Scholar
• BleeckerERLotvallJO’ByrnePMFluticasone furoate-vilanterol 100-25 mcg compared with fluticasone furoate 100 mcg in asthma: a randomized trialJ Allergy Clin Immunol Pract20142555356125213048
   PubMed Web of Science ®Google Scholar
• BatemanEDO’ByrnePMBusseWWOnce-daily fluticasone furoate (FF)/vilanterol reduces risk of severe exacerbations in asthma versus FF aloneThorax201469431231924253831
   PubMed Web of Science ®Google Scholar
• O’ByrnePMBleeckerERBatemanEDOnce-daily fluticasone furoate alone or combined with vilanterol in persistent asthmaEur Respir J201443377378224136330
   PubMed Web of Science ®Google Scholar
• OliverAVanBurenSAllenATolerability of fluticasone furoate/vilanterol combination therapy in children aged 5 to 11 years with persistent asthmaClin Ther2014366928e921939e92124793536
   PubMed Web of Science ®Google Scholar
• BusseWWO’ByrnePMBleeckerERSafety and tolerability of the novel inhaled corticosteroid fluticasone furoate in combination with the beta2 agonist vilanterol administered once daily for 52 weeks in patients >=12 years old with asthma: a randomised trialThorax201368651352023440247
   PubMed Web of Science ®Google Scholar
• KempsfordRDOliverABalJTombsLQuinnDThe efficacy of once-daily fluticasone furoate/vilanterol in asthma is comparable with morning or evening dosingRespir Med2013107121873188024200619
   PubMed Web of Science ®Google Scholar
• WoodcockABleeckerERLotvallJEfficacy and safety of fluticasone furoate/vilanterol compared with fluticasone propionate/salmeterol combination in adult and adolescent patients with persistent asthma: a randomized trialChest201314441222122923846316
   PubMed Web of Science ®Google Scholar
• LinJTangHChenPEfficacy and safety evaluation of once-daily fluticasone furoate/vilanterol in Asian patients with asthma uncontrolled on a low- to mid-strength inhaled corticosteroid or low-dose inhaled corticosteroid/long-acting beta2-agonistAllergy Asthma Proc201637430231027401316
   PubMed Web of Science ®Google Scholar
• LinJKangJLeeSHFluticasone furoate/vilanterol 200/25 mcg in Asian asthma patients: a randomized trialRespir Med20151091445325524507
   PubMed Web of Science ®Google Scholar
• Dal NegroRWDistanteCBonadimanLTurcoPIannazzoSFluticasone furoate/vilanterol 92/22 mug once-a-day vs beclomethasone dipropionate/formoterol 100/6 mug b.i.d.: a 12-week cost analysis in mild-to-moderate asthmaMultidiscip Respir Med2016112027275384
   PubMedGoogle Scholar
• HozawaSTeradaMHarutaYHozawaMComparison of early effects of budesonide/formoterol maintenance and reliever therapy with fluticasone furoate/vilanterol for asthma patients requiring step-up from inhaled corticosteroid monotherapyPulm Pharmacol Ther201637152326850307
   PubMed Web of Science ®Google Scholar
• LouieSZekiAASchivoMThe asthma-chronic obstructive pulmonary disease overlap syndrome: pharmacotherapeutic considerationsExpert Rev Clin Pharmacol20136219721923473596
   PubMed Web of Science ®Google Scholar
• IshiuraYFujimuraMShibaYOhkuraNHaraJKasaharaKA comparison of the efficacy of once-daily fluticasone furoate/vilanterol with twice-daily fluticasone propionate/salmeterol in asthma-COPD overlap syndromePulm Pharmacol Ther201535283326497109
   PubMed Web of Science ®Google Scholar
• WoodcockABakerlyNDNewJPThe Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in asthmaBMC Pulm Med20151516026651333
   PubMed Web of Science ®Google Scholar
• GrossASGoldfradCHozawaSEthnic sensitivity assessment of fluticasone furoate/vilanterol in East Asian asthma patients from randomized double-blind multicentre phase IIb/III trialsBMC Pulm Med20151516526704701
   PubMed Web of Science ®Google Scholar
• RodrigoGJPlazaVOnce-daily fluticasone furoate and vilanterol for adolescents and adults with symptomatic asthma: a systematic review with meta-analysisAnn Allergy Asthma Immunol2016116656557027117053
   PubMed Web of Science ®Google Scholar
• IngersollKSCohenJThe impact of medication regimen factors on adherence to chronic treatment: a review of literatureJ Behav Med200831321322418202907
   PubMed Web of Science ®Google Scholar
• ColemanCILimoneBSobierajDMDosing frequency and medication adherence in chronic diseaseJ Manag Care Pharm201218752753922971206
   PubMed Web of Science ®Google Scholar
• LindsayJTHeaneyLGNon-adherence in difficult asthma and advances in detectionExpert Rev Respir Med20137660761424164107
   PubMed Web of Science ®Google Scholar
• FischerJWimmerAMahlichJMedication adherence in asthma therapy – a structured reviewPneumologie201367740641423797492
   PubMedGoogle Scholar
• LindsayJTHeaneyLGNonadherence in difficult asthma – facts, myths, and a time to actPatient Prefer Adherence2013732933623723690
   PubMed Web of Science ®Google Scholar
• BenderBMilgromHRandCNonadherence in asthmatic patients: is there a solution to the problem?Ann Allergy Asthma Immunol1997793177185 quiz185–1769305223
   PubMed Web of Science ®Google Scholar
• BenderBMilgromHApterAAdherence intervention research: what have we learned and what do we do next?J Allergy Clin Immunol2003112348949413679805
   PubMed Web of Science ®Google Scholar
• FeehanMRankerLDuranteRAdherence to controller asthma medications: 6-month prevalence across a US community pharmacy chainJ Clin Pharm Ther Epub2015820
   PubMed Web of Science ®Google Scholar
• McNallyKARohanJSchluchterMAdherence to combined montelukast and fluticasone treatment in economically disadvantaged African American youth with asthmaJ Asthma200946992192719905919
   PubMed Web of Science ®Google Scholar
• ShamsMRFinemanSMAsthma adherence: how can we help our patients do it better?Ann Allergy Asthma Immunol2014112191224331386
   PubMed Web of Science ®Google Scholar
• HeaneyLGHorneRNon-adherence in difficult asthma: time to take it seriouslyThorax201267326827021685491
   PubMed Web of Science ®Google Scholar
• KomaseYAsakoAKobayashiASharmaREase-of-use preference for the ELLIPTA(R) dry powder inhaler over a commonly used single-dose capsule dry powder inhaler by inhalation device-naive Japanese volunteers aged 40 years or olderInt J Chron Obstruct Pulmon Dis201491365137525525354
   PubMed Web of Science ®Google Scholar
• SvedsaterHDalePGarrillKWalkerRWoepseMWQualitative assessment of attributes and ease of use of the ELLIPTA dry powder inhaler for delivery of maintenance therapy for asthma and COPDBMC Pulm Med2013137224314123
   PubMed Web of Science ®Google Scholar
• Yun KirbySZhuCQKerwinEMStanfordRHGeorgesGA preference study of two placebo dry powder inhalers in adults with COPD: ELLIPTA(R) dry powder inhaler (DPI) versus DISKUS(R) DPICOPD201613216717526516724
   PubMedGoogle Scholar
• BrealeyNGuptaARenauxJMehtaRAllenAHendersonAPharmacokinetics of fluticasone furoate, umeclidinium, and vilanterol as a triple therapy in healthy volunteersInt J Clin Pharmacol Ther201553975376426227101
   PubMed Web of Science ®Google Scholar
• BatemanEDBleeckerERLotvallJDose effect of once-daily fluticasone furoate in persistent asthma: a randomized trialRespir Med2012106564265022342538
   PubMed Web of Science ®Google Scholar
• LötvallJBleeckerERBusseWWEfficacy and safety of fluticasone furoate 100 mug once-daily in patients with persistent asthma: a 24-week placebo and active-controlled randomised trialRespir Med20141081414924295556
   PubMed Web of Science ®Google Scholar
• BusseWWBatemanEDO’ByrnePMOnce-daily fluticasone furoate 50 mcg in mild-to-moderate asthma: a 24-week placebo-controlled randomized trialAllergy201469111522153025040613
   PubMed Web of Science ®Google Scholar
• O’ByrnePMWoodcockABleeckerEREfficacy and safety of once-daily fluticasone furoate 50 mcg in adults with persistent asthma: a 12-week randomized trialRespir Res2014158825108545
   PubMed Web of Science ®Google Scholar
• WoodcockABleeckerERBusseWWFluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthmaRespir Res20111216022188590
   PubMed Web of Science ®Google Scholar
• MedleyHOrozcoSAllenAEfficacy and safety profile of fluticasone furoate administered once daily in the morning or evening: a randomized, double-blind, double-dummy, placebo-controlled trial in adult and adolescent patients with persistent bronchial asthmaClin Ther20123481683169522796247
   PubMed Web of Science ®Google Scholar
• BusseWWBleeckerERBatemanEDFluticasone furoate demonstrates efficacy in patients with asthma symptomatic on medium doses of inhaled corticosteroid therapy: an 8-week, randomised, placebo-controlled trialThorax2012671354121828231
   PubMed Web of Science ®Google Scholar
• BleeckerERBatemanEDBusseWWOnce-daily fluticasone furoate is efficacious in patients with symptomatic asthma on low-dose inhaled corticosteroidsAnn Allergy Asthma Immunol20121095353e354358e35423062392
   PubMed Web of Science ®Google Scholar
• van den BergeMLuijkBBareillePDallowNPostmaDSLammersJWProlonged protection of the new inhaled corticosteroid fluticasone furoate against AMP hyperresponsiveness in patients with asthmaAllergy201065121531153520560909
   PubMed Web of Science ®Google Scholar
• AllenABalJCheesbroughAHamiltonMKempsfordRPharmacokinetics and pharmacodynamics of intravenous and inhaled fluticasone furoate in healthy Caucasian and East Asian subjectsBr J Clin Pharmacol201477580882024152086
   PubMed Web of Science ®Google Scholar
• OliverAVanBurenSAllenASafety, tolerability, pharmacokinetics, and pharmacodynamics of vilanterol, a novel inhaled long-acting beta-agonist, in children aged 5–11 years with persistent asthma: a randomized trialClin Pharmacol Drug Dev20143321522126097789
   PubMed Web of Science ®Google Scholar
• AllenRAWuWYaoMNerve regeneration and elastin formation within poly(glycerol sebacate)-based synthetic arterial grafts one-year post-implantation in a rat modelBiomaterials201435116517324119457
   PubMed Web of Science ®Google Scholar
• CalzettaLRinaldiBCazzolaMMateraMGPharmacodynamic and pharmacokinetic assessment of fluticasone furoate + vilanterol for the treatment of asthmaExpert Opin Drug Metab Toxicol201612781382227253498
   PubMed Web of Science ®Google Scholar
• AllenASchenkenbergerITrivediRInhaled fluticasone furoate/vilanterol does not affect hypothalamic-pituitary-adrenal axis function in adolescent and adult asthma: randomised, double-blind, placebo-controlled studyClin Respir J20137439740623578031
   PubMed Web of Science ®Google Scholar
• OliverAQuinnDGoldfradCvan HeckeBAyerJBoyceMCombined fluticasone furoate/vilanterol reduces decline in lung function following inhaled allergen 23 h after dosing in adult asthma: a randomised, controlled trialClin Transl Allergy2012211122738148
   PubMedGoogle Scholar