메뉴 건너뛰기




Volumn 77, Issue 3, 2014, Pages 466-479

A repeat-dose thorough QT study of inhaled fluticasone furoate/vilanterol combination in healthy subjects

Author keywords

fluticasone furoate; healthy subjects; moxifloxacin; thorough QT; vilanterol

Indexed keywords

FLUTICASONE FUROATE; HEALTHY SUBJECTS; MOXIFLOXACIN; THOROUGH QT; VILANTEROL;

EID: 84894452245     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/bcp.12243     Document Type: Article
Times cited : (17)

References (49)
  • 1
    • 73449086493 scopus 로고    scopus 로고
    • Global Initiative for Asthma (GINA) [internet] Available at (last accessed 11 October 2012)
    • Global Initiative for Asthma (GINA) [internet]. Global strategy for asthma management and prevention. 2011. Available at http://www.ginasthma.org (last accessed 11 October 2012).
    • (2011) Global Strategy for Asthma Management and Prevention
  • 5
    • 84857138876 scopus 로고    scopus 로고
    • Fluticasone furoate (FF), an inhaled corticosteroid (ICS), is efficacious in asthma patients symptomatic on low doses of ICS therapy
    • Bleecker ER, Bateman ED, Busse W, Lötvall J, Woodcock A, Tomkins S, House K, Jacques L, Haumann B,. Fluticasone furoate (FF), an inhaled corticosteroid (ICS), is efficacious in asthma patients symptomatic on low doses of ICS therapy. Eur Respir J 2010; 36 (Suppl. 54): S204.
    • (2010) Eur Respir J , vol.36 , Issue.SUPPL. 54
    • Bleecker, E.R.1    Bateman, E.D.2    Busse, W.3    Lötvall, J.4    Woodcock, A.5    Tomkins, S.6    House, K.7    Jacques, L.8    Haumann, B.9
  • 6
    • 84855187266 scopus 로고    scopus 로고
    • Fluticasone furoate demonstrates efficacy in patients with asthma symptomatic on medium doses of inhaled corticosteroid therapy: An 8-week, randomised, placebo-controlled trial
    • Busse WW, Bleecker ER, Bateman ED, Lötvall J, Forth R, Davis AM, Jacques L, Haumann B, Woodcock A,. Fluticasone furoate demonstrates efficacy in patients with asthma symptomatic on medium doses of inhaled corticosteroid therapy: an 8-week, randomised, placebo-controlled trial. Thorax 2012; 67: 35-41.
    • (2012) Thorax , vol.67 , pp. 35-41
    • Busse, W.W.1    Bleecker, E.R.2    Bateman, E.D.3    Lötvall, J.4    Forth, R.5    Davis, A.M.6    Jacques, L.7    Haumann, B.8    Woodcock, A.9
  • 11
    • 79959363358 scopus 로고    scopus 로고
    • 2-adrenoreceptor agonist
    • 2-adrenoreceptor agonist. Core Evid 2009; 4: 37-41.
    • (2009) Core Evid , vol.4 , pp. 37-41
    • Beeh, K.M.1    Beier, J.2
  • 12
    • 12144283069 scopus 로고    scopus 로고
    • Past, present and future-beta2-adrenoceptor agonists in asthma management
    • Sears MR, Lötvall J,. Past, present and future-beta2-adrenoceptor agonists in asthma management. Respir Med 2005; 99: 152-170.
    • (2005) Respir Med , vol.99 , pp. 152-170
    • Sears, M.R.1    Lötvall, J.2
  • 13
    • 36649002044 scopus 로고    scopus 로고
    • Indacaterol provides sustained 24 h bronchodilation on once-daily dosing in asthma: A 7-day dose-ranging study
    • LaForce C, Alexander M, Deckelmann R, Fabbri LM, Aisanov Z, Cameron R, Owen R, Higgins M,. Indacaterol provides sustained 24 h bronchodilation on once-daily dosing in asthma: a 7-day dose-ranging study. Allergy 2008; 63: 103-111.
    • (2008) Allergy , vol.63 , pp. 103-111
    • Laforce, C.1    Alexander, M.2    Deckelmann, R.3    Fabbri, L.M.4    Aisanov, Z.5    Cameron, R.6    Owen, R.7    Higgins, M.8
  • 14
    • 70349090618 scopus 로고    scopus 로고
    • Emerging inhaled bronchodilators: An update
    • Cazzola M, Matera MG,. Emerging inhaled bronchodilators: an update. Eur Respir J 2009; 34: 757-769.
    • (2009) Eur Respir J , vol.34 , pp. 757-769
    • Cazzola, M.1    Matera, M.G.2
  • 15
    • 76949107791 scopus 로고    scopus 로고
    • Improved adherence with once-daily versus twice-daily dosing of mometasone furoate administered via a dry powder inhaler: A randomized open-label study
    • Price D, Robertson A, Bullen K, Rand C, Horne R, Staudinger H,. Improved adherence with once-daily versus twice-daily dosing of mometasone furoate administered via a dry powder inhaler: a randomized open-label study. BMC Pulm Med 2010; 10: 1.
    • (2010) BMC Pulm Med , vol.10 , pp. 1
    • Price, D.1    Robertson, A.2    Bullen, K.3    Rand, C.4    Horne, R.5    Staudinger, H.6
  • 16
    • 2942744546 scopus 로고    scopus 로고
    • Cardiovascular effects of β-agonists in patients with asthma and COPD
    • Salpeter SR, Thomas TM, Salpeter EE,. Cardiovascular effects of β-agonists in patients with asthma and COPD. Chest 2004; 125: 2309-2321.
    • (2004) Chest , vol.125 , pp. 2309-2321
    • Salpeter, S.R.1    Thomas, T.M.2    Salpeter, E.E.3
  • 17
    • 33646895864 scopus 로고    scopus 로고
    • Literature review and pilot studies of the effect of QT correction formulas on reported beta2-agonist-induced QTc prolongation
    • Milic M, Bao X, Rizos D, Liu F, Ziegler MG,. Literature review and pilot studies of the effect of QT correction formulas on reported beta2-agonist- induced QTc prolongation. Clin Ther 2006; 28: 582-590.
    • (2006) Clin Ther , vol.28 , pp. 582-590
    • Milic, M.1    Bao, X.2    Rizos, D.3    Liu, F.4    Ziegler, M.G.5
  • 18
    • 33746627036 scopus 로고    scopus 로고
    • US Department of Health and Human Services Food and Drug Administration (FDA) [internet] Food and Drug Administration. Available at (last accessed 11 October 2012)
    • US Department of Health and Human Services Food and Drug Administration (FDA) [internet]. Guidance for industry. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. Food and Drug Administration. 2005. Available at http://www.fda.gov/downloads/ RegulatoryInformation/Guidances/ucm129357.pdf (last accessed 11 October 2012).
    • (2005) Guidance for Industry. E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs
  • 20
  • 23
    • 84980098899 scopus 로고
    • Duration of systole in electrocardiogram
    • Fridericia LS,. Duration of systole in electrocardiogram. Acta Med Scandinav 1920; 53: 469-486.
    • (1920) Acta Med Scandinav , vol.53 , pp. 469-486
    • Fridericia, L.S.1
  • 24
    • 0001127258 scopus 로고
    • An analysis of time relations of electrocardiograms
    • Bazett HC,. An analysis of time relations of electrocardiograms. Heart 1920; 7: 353-367.
    • (1920) Heart , vol.7 , pp. 353-367
    • Bazett, H.C.1
  • 25
    • 0036181222 scopus 로고    scopus 로고
    • Relation between QT and RR intervals is highly individual among healthy subjects: Implications for heart rate correction of the QT interval
    • Malik M, Farbom P, Batchvarov V, Hnatkova K, Camm AJ,. Relation between QT and RR intervals is highly individual among healthy subjects: implications for heart rate correction of the QT interval. Heart 2002; 87: 220-228.
    • (2002) Heart , vol.87 , pp. 220-228
    • Malik, M.1    Farbom, P.2    Batchvarov, V.3    Hnatkova, K.4    Camm, A.J.5
  • 27
    • 84884820913 scopus 로고    scopus 로고
    • Health Canada [internet] Available at (last accessed 12 October 2012)
    • Health Canada [internet]. Revised guide for the analysis and review of QT/QTc interval data. 2010. Available at http://www.hc-sc.gc.ca/dhp-mps/ prodpharma/applic-demande/guideld/qtqtc/qt-review-examen-eng.php#rate (last accessed 12 October 2012).
    • (2010) Revised Guide for the Analysis and Review of QT/QTc Interval Data
  • 30
    • 0002322365 scopus 로고    scopus 로고
    • Xpose - An S-PLUS based population pharmacokinetic/pharmacodynamics model building aid for NONMEM
    • Jonsson EN, Karlsson MO,. Xpose-an S-PLUS based population pharmacokinetic/pharmacodynamics model building aid for NONMEM. Comput Methods Programs Biomed 1999; 58: 51-64.
    • (1999) Comput Methods Programs Biomed , vol.58 , pp. 51-64
    • Jonsson, E.N.1    Karlsson, M.O.2
  • 31
    • 43949145260 scopus 로고    scopus 로고
    • Extensions to the Visual Predictive Check to facilitate model performance evaluation
    • Post TM, Freijer JI, Ploeger BA, Manhof M,. Extensions to the Visual Predictive Check to facilitate model performance evaluation. J Pharmacokinet Pharmacodyn 2008; 35: 185-202.
    • (2008) J Pharmacokinet Pharmacodyn , vol.35 , pp. 185-202
    • Post, T.M.1    Freijer, J.I.2    Ploeger, B.A.3    Manhof, M.4
  • 32
    • 0026468048 scopus 로고
    • QT intervals at heart rates from 50 to 120 beats per minute during 24-hour electrocardiographic recordings in 100 healthy men. Effects of atenolol
    • Vitasalo M, Karjalainen J,. QT intervals at heart rates from 50 to 120 beats per minute during 24-hour electrocardiographic recordings in 100 healthy men. Effects of atenolol. Circulation 1992; 86: 1439-1442.
    • (1992) Circulation , vol.86 , pp. 1439-1442
    • Vitasalo, M.1    Karjalainen, J.2
  • 33
    • 0035043773 scopus 로고    scopus 로고
    • Problems of heart rate correction in assessment of drug-induced QT interval prolongation
    • Malik M,. Problems of heart rate correction in assessment of drug-induced QT interval prolongation. J Cardiovasc Electrophysiol 2001; 12: 411-420.
    • (2001) J Cardiovasc Electrophysiol , vol.12 , pp. 411-420
    • Malik, M.1
  • 34
    • 74549120726 scopus 로고    scopus 로고
    • The thorough QT/QTc study 4 years after the implementation of the ICH E14 guidance
    • Darpo B,. The thorough QT/QTc study 4 years after the implementation of the ICH E14 guidance. Br J Pharmacol 2010; 159: 49-57.
    • (2010) Br J Pharmacol , vol.159 , pp. 49-57
    • Darpo, B.1
  • 35
    • 74549216361 scopus 로고    scopus 로고
    • Update on the evaluation of a new drug for effects of cardiac repolarization in humans: Issues in early drug development
    • Salvi V, Karnad DR, Panicker GK, Kothari S,. Update on the evaluation of a new drug for effects of cardiac repolarization in humans: issues in early drug development. Br J Pharmacol 2010; 159: 34-48.
    • (2010) Br J Pharmacol , vol.159 , pp. 34-48
    • Salvi, V.1    Karnad, D.R.2    Panicker, G.K.3    Kothari, S.4
  • 36
    • 84874563028 scopus 로고    scopus 로고
    • Vilanterol trifenatate, a novel inhaled long-acting beta2 adrenoceptor agonist, is well tolerated in healthy subjects and demonstrates prolonged bronchodilation in subjects with asthma and COPD
    • Kempsford R, Norris V, Siederer S,. Vilanterol trifenatate, a novel inhaled long-acting beta2 adrenoceptor agonist, is well tolerated in healthy subjects and demonstrates prolonged bronchodilation in subjects with asthma and COPD. Pulm Pharmacol Ther 2013; 26: 256-264.
    • (2013) Pulm Pharmacol Ther , vol.26 , pp. 256-264
    • Kempsford, R.1    Norris, V.2    Siederer, S.3
  • 37
    • 84876147855 scopus 로고    scopus 로고
    • Systemic inflammatory biomarkers and co-morbidities of chronic obstructive pulmonary disease
    • MacNee W,. Systemic inflammatory biomarkers and co-morbidities of chronic obstructive pulmonary disease. Ann Med 2013; 45: 291-300.
    • (2013) Ann Med , vol.45 , pp. 291-300
    • Macnee, W.1
  • 38
    • 84875257111 scopus 로고    scopus 로고
    • A randomised trial of fluticasone fuorate/vilanterol (50/25 μg; 100/25 μg) on lung function in COPD
    • Kerwin EM, Scott-Wilson C, Sanford L, Rennard S, Agusti A, Barnes N, Crim C,. A randomised trial of fluticasone fuorate/vilanterol (50/25 μg; 100/25 μg) on lung function in COPD. Respir Med 2013; 107: 560-569.
    • (2013) Respir Med , vol.107 , pp. 560-569
    • Kerwin, E.M.1    Scott-Wilson, C.2    Sanford, L.3    Rennard, S.4    Agusti, A.5    Barnes, N.6    Crim, C.7
  • 40
    • 84877615735 scopus 로고    scopus 로고
    • Safety and tolerability of the novel inhaled corticosteroid fluticasone fuorate in combination with the b2 agonist vilanterol administered once daily for 52 weeks in patients ≥ 12 years old with asthma: A randomised trial
    • Busse WW, O'Byrne PM, Bleecker ER, Lotvall J, Woodcock A, Andersen L, Hicks W, Crawford J, Jacques L, Apoux L, Bateman ED,. Safety and tolerability of the novel inhaled corticosteroid fluticasone fuorate in combination with the b2 agonist vilanterol administered once daily for 52 weeks in patients ≥ 12 years old with asthma: a randomised trial. Thorax 2013; 68: 513-520.
    • (2013) Thorax , vol.68 , pp. 513-520
    • Busse, W.W.1    O'Byrne, P.M.2    Bleecker, E.R.3    Lotvall, J.4    Woodcock, A.5    Andersen, L.6    Hicks, W.7    Crawford, J.8    Jacques, L.9    Apoux, L.10    Bateman, E.D.11
  • 41
    • 84873050710 scopus 로고    scopus 로고
    • Fluticasone furoate, a novel inhaled corticosteroid, demonstrates prolonged lung absorption kinetics in man compared with inhaled fluticasone propionate
    • Allen A, Bareille PJ, Rousell VM,. Fluticasone furoate, a novel inhaled corticosteroid, demonstrates prolonged lung absorption kinetics in man compared with inhaled fluticasone propionate. Clin Pharmacokinet 2013; 52: 37-42.
    • (2013) Clin Pharmacokinet , vol.52 , pp. 37-42
    • Allen, A.1    Bareille, P.J.2    Rousell, V.M.3
  • 42
    • 79957457853 scopus 로고    scopus 로고
    • Cardiac safety of indacaterol in healthy subjects: A randomized, multidose, placebo- and positive-controlled, parallel-group thorough QT study
    • Khindri S, Sabo R, Harris S, Woessner R, Jennings S, Drollmann AF,. Cardiac safety of indacaterol in healthy subjects: a randomized, multidose, placebo- and positive-controlled, parallel-group thorough QT study. BMC Pulmonary Medicine 2011; 11: 31.
    • (2011) BMC Pulmonary Medicine , vol.11 , pp. 31
    • Khindri, S.1    Sabo, R.2    Harris, S.3    Woessner, R.4    Jennings, S.5    Drollmann, A.F.6
  • 44
    • 84863523852 scopus 로고    scopus 로고
    • The safety, tolerability, pharmacodynamics and pharmacokinetics of inhaled fluticasone furoate (FF) and vilanterol (VI) are unaffected by administration in combination
    • Kempsford R, Allen A, Bareille P, Bishop H, Hamilton M, Cheesbrough A,. The safety, tolerability, pharmacodynamics and pharmacokinetics of inhaled fluticasone furoate (FF) and vilanterol (VI) are unaffected by administration in combination. Eur Respir J 2011; 38 (Suppl. 55): S138.
    • (2011) Eur Respir J , vol.38 , Issue.SUPPL. 55
    • Kempsford, R.1    Allen, A.2    Bareille, P.3    Bishop, H.4    Hamilton, M.5    Cheesbrough, A.6
  • 45
    • 45849146583 scopus 로고    scopus 로고
    • Statistical assessment of QT data following placebo and moxifloxacin dosing in thorough QT studies
    • Stylianou A, Roger J, Stephens KA,. Statistical assessment of QT data following placebo and moxifloxacin dosing in thorough QT studies. J Biopharm Stat 2008; 18: 502-516.
    • (2008) J Biopharm Stat , vol.18 , pp. 502-516
    • Stylianou, A.1    Roger, J.2    Stephens, K.A.3
  • 48
    • 84870749810 scopus 로고    scopus 로고
    • Influence of renal and hepatic impairment on the pharmacokinetic and pharmacodymanic properties and tolerability of fluticasone furoate and vilanterol in combination
    • Allen A, Davis A, Hardes K, Tombs L, Kempsford R,. Influence of renal and hepatic impairment on the pharmacokinetic and pharmacodymanic properties and tolerability of fluticasone furoate and vilanterol in combination. Clin Ther 2012; 34: 2316-2332.
    • (2012) Clin Ther , vol.34 , pp. 2316-2332
    • Allen, A.1    Davis, A.2    Hardes, K.3    Tombs, L.4    Kempsford, R.5
  • 49
    • 84878135015 scopus 로고    scopus 로고
    • The effect of ketoconazole on the pharmacokinetics and pharmacodynamics of inhaled fluticasone furoate and vilanterol in healthy subjects
    • Kempsford R, Allen A, Rubin D, Bal J, Tombs L,. The effect of ketoconazole on the pharmacokinetics and pharmacodynamics of inhaled fluticasone furoate and vilanterol in healthy subjects. Br J Clin Pharmacol 2013; 75: 1478-1487
    • (2013) Br J Clin Pharmacol , vol.75 , pp. 1478-1487
    • Kempsford, R.1    Allen, A.2    Rubin, D.3    Bal, J.4    Tombs, L.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.