281
Views
3
CrossRef citations to date
0
Altmetric
Drug Profile

Fluticasone furoate and vilanterol trifenatate combination therapy for the treatment of asthma

, &
Pages 839-847 | Received 17 Dec 2015, Accepted 12 May 2016, Published online: 08 Jun 2016

References

  • Fanta C. Drug therapy, asthma. N Engl J Med. 2009;360:1002–1014.
  • Shore S. Airway smooth muscle in asthma - not just more of the same. N Engl J Med. 2004;351:531–532.
  • Johnson P, Roth M, Tamm M, et al. Airway smooth muscle cell proliferation is increased in asthma. Am J Respir Crit Care Med. 2001;164:474–477.
  • Procopiou PA, Barrett VJ, Bevan NJ, et al. Synthesis and structure-activity relationships of long-acting ß2 adrenergic receptor agonists incorporating metabolic inactivation: an antedrug approach. J Med Chem. 2010;53(11):4522–4530.
  • Johnson E, Druey K. Heterotrimeric G protein signaling: role in asthma and allergic inflammation. J Allergy Clin Immunol. 2002;109(4):592–602.
  • Barnes P. Biochemical basis of asthma therapy. J Biol Chem. 2011;286(38):32899–32905.
  • Jaeschke R, O’Byrne PM, Mejza F, et al. The safety of long-acting beta-agonists among patients with asthma using inhaled corticosteroids: systematic review and meta-analysis. Am J Respir Crit Care Med. 2008;178:1009–1016.
  • Castle W, Fuller R, Hall J, et al. Serevent nationwide surveillance study: comparison of salmeterol with salbutamol in asthmatic patients who require regular bronchodilator treatment. BMJ. 1993;306(6884):1034–1037.
  • Salpeter S, Buckley NS, Ormiston TM, et al. Meta-analysis: effect of long-acting beta-agonists on severe asthma exacerbations and asthma-related deaths. Ann Intern Med. 2006;144(12):904–912.
  • Nelson HS, Weiss S, Bleecker ER, et al.; SMART Study Group. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest. 2006;129(1):15–26.
  • Salter M, Biggadike K, Matthews JL, et al. Pharmacological properties of the enhanced-affinity glucocorticoid fluticasone furoate in vitro and in an in vivo model of respiratory inflammatory disease. Am J Physiol Lung Cell Mol Physiol. 2007;293(3):L660–L667.
  • Wadsworth S, Nijmeh H, Hall I. Glucocorticoids increase repair potential in a novel in vitro human airway epithelial wounding model. J Clin Immunol. 2006;26:376–387.
  • West MR, Matthews J, Man Y, et al. Glucocorticoids alter the barrier efficacy of bronchial epithelial cells. Am J Respir Crit Care Med. 2001;163:A997.
  • Chanez P, Bourdin A, Vachier I, et al. Effects of inhaled corticosteroids on pathology in asthma and chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2004;1:184–190.
  • Lundgren R, Söderberg M, Hörstedt P, et al. Morphological studies of bronchial mucosal biopsies from asthmatics before and after ten years of treatment with inhaled steroids. Eur Respir J. 1988;1:883–889.
  • Donahue J, Weiss S, Livingston J, et al. Inhaled steroids and the risk of hospitalisation for asthma. JAMA. 1997;277:887–891.
  • Suissa S, Ernst P, Benayoun S, et al. Low-dose inhaled corticosteroids and the prevention of death from asthma. N Engl J Med. 2000;343:332–336.
  • Friedman H, Navaratnam P, McLaughlin J. Adherence and asthma control with mometasone furoate versus fluticasone propionate in adolescents and young adults with mild asthma. J Asthma. 2010;47(9):994–1000.
  • Price D, Robertson A, Bullen K, et al. Improved adherence with once-daily versus twice-daily dosing of mometasone furoate administered via a dry powder inhaler: a randomised open-label study. BMC Pulm Med. 2010;10:1.
  • Baraniuk J, Ali M, Brody D, et al. Glucocorticoids induce beta2-adrenergic receptor function in human nasal mucosa. Am J Respir Crit Care Med. 1997;155:704–710.
  • Eickelberg O, Roth M, Lorx R, et al. Ligand-independent activation of the glucocorticoid receptor by beta-2 adrenergic receptor agonists in primary human lung fibroblasts and vascular smooth muscle cells. J Biol Chem. 1999;274:1005–1010.
  • Barnes P. Scientific rationale for inhaled combination therapy with long-acting beta2-agonists and corticosteroids. Eur Respir J. 2002;19:182–191.
  • Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. National Heart, Lung and Blood Institute (NHLBI); 2015. Available from: www.ginasthma.org
  • Kankaanranta H, Lahdensuo A, Moilanen E, et al. Add-on therapy options in asthma not adequately controlled by inhaled corticosteroids: a comprehensive review. Respir Res. 2004;5:17.
  • Toogood J, White F, Baskerville J, et al. Comparison of the antiasthmatic, oropharyngeal, and systemic glucocorticoid effects of budesonide administered through a pressurized aerosol plus spacer or the Turbuhaler dry powder inhaler. J Allergy Clin Immunol. 1997;99:186–193.
  • Inman M, Watson R, Rerecich T, et al. Dose-dependent effects of inhaled mometasone furoate on airway function and inflammation after allergen inhalation challenge. Am J Respir Crit Care Med. 2001;164:569–574.
  • Silkoff P, McClean P, Spino M, et al. Dose-response relationship and reproducibility of the fall in exhaled nitric oxide after inhaled beclomethasone dipropionate therapy in asthma patients. Chest. 2001;119:1322–1328.
  • Gibson P, Powell H, Ducharme F. Differential effects of maintenance long-acting ß-agonist and inhaled corticosteroid on asthma control and asthma exacerbations. J Allergy Clin Immunol. 2007;119:344–350.
  • Price D, Hernandez D, Magyar P, et al. Randomised controlled trial of montelukast plus inhaled budesonide versus double dose inhaled budesonide in adult patients with asthma. Thorax. 2003;58:211–216.
  • Smith I, Parry-Billings M. The inhalers of the future? A review of dry powder devices on the market today. Pulm Pharmacol Ther. 2003;16:79–95.
  • Newman S. Dry powder inhalers for optimal drug delivery. Expert Opin Biol Ther. 2004;4(1):23–22.
  • Thorsson L, Kenyon C, Newman S, et al. Lung deposition of budesonide in asthmatics: a comparison of different formulations. Int J Pharm. 1998;168:119–127.
  • Thorsson L, Edsbacker S, Conradson T-B. Lung deposition of budesonide from Turbuhaler is twice that from a pressurised metered dose inhaler P-MDI. Eur Respir J. 1994;7:1839–1844.
  • Borgstrom L, Bondesson E, Moren F, et al. Lung deposition of budesonide inhaled via Turbuhaler: a comparison with terbutaline sulphate in normal subjects. Eur Respir J. 1994;7:69–73.
  • Johnson M. Fluticasone propionate: pharmacokineticand pharmacodynamic implications of different aerosol delivery systems. In: Dalby R, Byron P, Farr S, editors. Respiratory drug delivery. Buffalo Grove (IL): Interpharm Press; 1998. p. 61–70.
  • Pitcairn G, Reader S, Pavia D, et al. Deposition of corticosteroid aerosol in the human lung by Respimat Soft Mist inhaler compared to deposition by metered dose inhaler or by Turbuhaler dry powder inhaler. J Aerosol Med. 2005;18(3):264–272.
  • Oliver A, Bjermer L, Quinn D, et al. Modulation of allergen-induced bronchoconstriction by fluticasone furoate and vilanterol alone or in combination. Allergy. 2013;68(9):1136–1142.
  • Kempsford RD, Oliver A, Bal J, et al. The efficacy of once-daily fluticasone furoate/vilanterol in asthma is comparable with morning or evening dosing. Respir Med. 2013;107(12):1873–1880.
  • Bleecker ER, Lotvall J, O’Byrne PM, et al. Fluticasone furoate-vilanterol 100-25µg compared with fluticasone furoate 100µg in asthma: a randomised trial. J Allergy Clin Immunol Pract. 2014;2(5):553–561.
  • Bateman ED, O’Byrne PM, Busse WW, et al. Once-daily fluticasone furoate (FF)/vilanterol reduces risk of severe exacerbations in asthma versus FF alone. Thorax. 2014;69(4):312–319.
  • Bernstein DI, Bateman ED, Woodcock A, et al. Fluticasone furoate (FF)/vilanterol (100/25mcg or 200/25mcg) or FF (100mcg) in persistent asthma. J Asthma. 2015;52(10):1073–1083.
  • Ducharme FM, Ni Chroinin M, Greenstone I, et al. Addition of long-acting beta2-agonists to inhaled corticosteroids versus same dose inhaled corticosteroids for chronic asthma in adults and children. Cochrane Database Syst Rev. 2010;5:CD005535.
  • Ni Chroinin M, Greenstone I, Lasserson TJ, et al. Addition of inhaled long-acting beta2-agonists to inhaled steroids as first line therapy for persistent asthma in steroid-naive adults and children. Cochrane Database Syst Rev. 2009;7:CD005307.
  • O’Byrne PM, Bleecker ER, Bateman ED, et al. Once-daily fluticasone furoate alone or combined with vilanterol in persistent asthma. Eur Respir J. 2014;43(3):773–782.
  • Woodcock A, Bleecker ER, Lotvall J, et al. Efficacy and safety of fluticasone furoate/vilanterol compared with fluticasone propionate/salmeterol combination in adult and adolescent patients with persistent asthma: a randomised trial. Chest. 2013;144(4):1222–1229.
  • Kempsford R, Allen A, Bareille P, et al. The Pharmacodynamcs, pharmacokinetics, safety and tolerability of inhaled fluticasone furoate and vilanterol administered alone or simultaneously as fluticasone furoate/vilanterol. Clin Pharm Drug Dev. 2015;4(1):2–11.
  • Busse WW, O’Byrne PM, Bleecker ER, et al. Safety and tolerability of the novel inhaled corticosteroid fluticasone furoate in combination with the β2 agonist vilanterol administered once daily for 52 weeks in patients ≥12 years old with asthma: a randomised trial. Thorax. 2013;68(6):513–520.
  • Allen A, Schenkenberger I, Trivedi R, et al. Inhaled fluticasone furoate/vilanterol does not affect hypothalamic-pituitary-adrenal axis function in adolescent and adult asthma: randomised, double-blind, placebo-controlled study. Clin Respir J. 2013;7(4):397–406.
  • Kempsford R, Allen A, Kelly K, et al. A repeat-dose thorough QT study of inhaled fluticasone furoate/vilanterol combination in healthy subjects. Brit J Clin Pharmacol. 2014;77(3):466–479.
  • Cates CJ, Wieland LS, Olezczuk M, et al. Safety of regular formoterol or salmeterol in adults with asthma: anoverview of Cochrane reviews. Cochrane Database Syst Rev. 2014;2:CD010314.
  • US Food and Drug Administration. FDA Drug Safety Communication: drug labels now contain updated recommendations on the appropriate use of long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs). Silver Spring (MD): US Department of Health and Human Services; 2010.
  • Stempel D, Raphiou I, Kral K, et al. Serious asthma events with fluticasone plus salmeterol versus fluticasone alone. N Engl J Med. 2016;374: 1822–1830. doi:10.1056/NEJMoa1511049.
  • Allen A, Davis A, Hardes K, et al. Influence of renal and hepatic impairment on the pharmacokinetic and pharmacodynamic properties and tolerability of fluticasone furoate and vilanterol in combination. Clin Ther. 2012;34(12):2316–2332.
  • Kempsford R, Allen A, Bal J, et al. The effect of ketoconazole on the pharmacokinetics and pharmacodynamics of inhaled fluticasone furoate and vilanterol trifenatate in healthy subjects. Br J Clin Pharmacol. 2013;75(6):1478–1487.
  • Kim RB, Wandel C, Leake B, et al. Interrelationship between substrates and inhibitors of human CYP3A and P-glycoprotein. Pharm Res. 1999;16(3):408–414.
  • Ward KW, Stelman GJ, Morgan JA, et al. Development of an in vivo preclinical screen model to estimate absorption and first-pass hepatic extraction of xenobiotics. II. Use of ketoconazole to identify P-glycoprotein/CYP3A-limited bioavailability in the monkey. Drug Metab Dispos. 2004;32(2):172–177.
  • Zhang L, Zhang Y, Huang SM. Scientific and regulatory perspectives on metabolizing enzyme-transporter interplay and its role in drug interactions: challenges in predicting drug interactions. Mol Pharm. 2009;6(6):1766–1774.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.