Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: The GLISTEN study - A randomised controlled trial

P.A. Frith; Philip Thompson; R. Ratnavadivel; C.L. Chang; P. Bremner; P. Day; C. Frenzel; N. Kurstjens; A. Waddell; A. Daniel; A. Khoussousi; A. Springfield; A. Veale; A.N. Graham; B. Gallagher; B.R. Pande; B. O'Kane; C. Jones; C. Baldi; C. Helm; C. O'Dochartaigh; D. Chambers; D. Quinn; D. Yull; D. Karthigesu; E. Then; F. Graham; F. Faigenbaum; G. Geddam; G. Cameron; H. Blom; H. Goldman; H. Snell; I. Chia; J. Jeong; J. Liew; J. Salvaris; J. Pryke; J. Reid; J. Kolbe; J. O'Sullivan; J. Pak; J. Upham; J. Feiber; J.O.M. Ford; K. Yong; K. Perrin; L. Noonan; L. Atlas; L. Murdoch; M. Pearce; M. Bloch; M. Holmes; M. Chia; M. Epton; M. Leadston; M.K. Tandon; M. Chitgopeker; N. Liebenberg; N. Hendry; O. Olaniyi; O. Singh; P. Kendall; P. Van Niekerk; R. Willet; R. Tomlins; S. Pillay; S. Sharifeh; S. Carson; S. Bingham; T. Walford; T. Erasmus; T. Claridge; Z. Hess

doi:10.1136/thoraxjnl-2014-206670

Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: The GLISTEN study - A randomised controlled trial

P.A. Frith, Philip Thompson, R. Ratnavadivel, C.L. Chang, P. Bremner, P. Day, C. Frenzel, N. Kurstjens, A. Waddell, A. Daniel, A. Khoussousi, A. Springfield, A. Veale, A.N. Graham, B. Gallagher, B.R. Pande, B. O'Kane, C. Jones, C. Baldi, C. HelmC. O'Dochartaigh, D. Chambers, D. Quinn, D. Yull, D. Karthigesu, E. Then, F. Graham, F. Faigenbaum, G. Geddam, G. Cameron, H. Blom, H. Goldman, H. Snell, I. Chia, J. Jeong, J. Liew, J. Salvaris, J. Pryke, J. Reid, J. Kolbe, J. O'Sullivan, J. Pak, J. Upham, J. Feiber, J.O.M. Ford, K. Yong, K. Perrin, L. Noonan, L. Atlas, L. Murdoch, M. Pearce, M. Bloch, M. Holmes, M. Chia, M. Epton, M. Leadston, M.K. Tandon, M. Chitgopeker, N. Liebenberg, N. Hendry, O. Olaniyi, O. Singh, P. Kendall, P. Van Niekerk, R. Willet, R. Tomlins, S. Pillay, S. Sharifeh, S. Carson, S. Bingham, T. Walford, T. Erasmus, T. Claridge, Z. Hess

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Abstract

Background: The optimal use of various therapeutic combinations for moderate/severe chronic obstructive pulmonary disease (COPD) is unclear. The GLISTEN trial compared the efficacy of two long-acting anti-muscarinic antagonists (LAMA), when combined with an inhaled corticosteroid (ICS) and a long-acting β2 agonist (LABA). Methods: This randomised, blinded, placebo-controlled trial in moderate/severe COPD patients compared once-daily glycopyrronium (GLY) 50 μg, once-daily tiotropium (TIO) 18 μg or placebo (PLA), when combined with salmeterol/fluticasone propionate (SAL/FP) 50/500 μg twice daily. The primary objective was to determine the non-inferiority of GLY+SAL/FP versus TIO+SAL/FP on trough FEV1 after 12 weeks. An important secondary objective was whether addition of GLY to SAL/FP was better than SAL/FP alone. Results: 773 patients (mean FEV1 57.2% predicted) were randomised; 84.9% completed the trial. At week 12, GLY+SAL/FP demonstrated non-inferiority to TIO +SAL/FP for trough FEV1: least square mean treatment difference (LSMdiff) -7 mL (SE 17.4) with a lower limit for non-inferiority of -60 mL. There was significant increase in week 12 trough FEV1 with GLY+SAL/FP versus PLA+SAL/FP (LSMdiff 101 mL, p

Original language	English
Pages (from-to)	519-527
Journal	Thorax
Volume	70
Issue number	6
DOIs	https://doi.org/10.1136/thoraxjnl-2014-206670
Publication status	Published - 2015

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Frith, P. A., Thompson, P., Ratnavadivel, R., Chang, C. L., Bremner, P., Day, P., Frenzel, C., Kurstjens, N., Waddell, A., Daniel, A., Khoussousi, A., Springfield, A., Veale, A., Graham, A. N., Gallagher, B., Pande, B. R., O'Kane, B., Jones, C., Baldi, C., ... Hess, Z. (2015). Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: The GLISTEN study - A randomised controlled trial. Thorax, 70(6), 519-527. https://doi.org/10.1136/thoraxjnl-2014-206670

@article{d7db067da3f14730b57fcb3c0442e48c,

title = "Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: The GLISTEN study - A randomised controlled trial",

abstract = "Background: The optimal use of various therapeutic combinations for moderate/severe chronic obstructive pulmonary disease (COPD) is unclear. The GLISTEN trial compared the efficacy of two long-acting anti-muscarinic antagonists (LAMA), when combined with an inhaled corticosteroid (ICS) and a long-acting β2 agonist (LABA). Methods: This randomised, blinded, placebo-controlled trial in moderate/severe COPD patients compared once-daily glycopyrronium (GLY) 50 μg, once-daily tiotropium (TIO) 18 μg or placebo (PLA), when combined with salmeterol/fluticasone propionate (SAL/FP) 50/500 μg twice daily. The primary objective was to determine the non-inferiority of GLY+SAL/FP versus TIO+SAL/FP on trough FEV1 after 12 weeks. An important secondary objective was whether addition of GLY to SAL/FP was better than SAL/FP alone. Results: 773 patients (mean FEV1 57.2% predicted) were randomised; 84.9% completed the trial. At week 12, GLY+SAL/FP demonstrated non-inferiority to TIO +SAL/FP for trough FEV1: least square mean treatment difference (LSMdiff) -7 mL (SE 17.4) with a lower limit for non-inferiority of -60 mL. There was significant increase in week 12 trough FEV1 with GLY+SAL/FP versus PLA+SAL/FP (LSMdiff 101 mL, p",

author = "P.A. Frith and Philip Thompson and R. Ratnavadivel and C.L. Chang and P. Bremner and P. Day and C. Frenzel and N. Kurstjens and A. Waddell and A. Daniel and A. Khoussousi and A. Springfield and A. Veale and A.N. Graham and B. Gallagher and B.R. Pande and B. O'Kane and C. Jones and C. Baldi and C. Helm and C. O'Dochartaigh and D. Chambers and D. Quinn and D. Yull and D. Karthigesu and E. Then and F. Graham and F. Faigenbaum and G. Geddam and G. Cameron and H. Blom and H. Goldman and H. Snell and I. Chia and J. Jeong and J. Liew and J. Salvaris and J. Pryke and J. Reid and J. Kolbe and J. O'Sullivan and J. Pak and J. Upham and J. Feiber and J.O.M. Ford and K. Yong and K. Perrin and L. Noonan and L. Atlas and L. Murdoch and M. Pearce and M. Bloch and M. Holmes and M. Chia and M. Epton and M. Leadston and M.K. Tandon and M. Chitgopeker and N. Liebenberg and N. Hendry and O. Olaniyi and O. Singh and P. Kendall and {Van Niekerk}, P. and R. Willet and R. Tomlins and S. Pillay and S. Sharifeh and S. Carson and S. Bingham and T. Walford and T. Erasmus and T. Claridge and Z. Hess",

year = "2015",

doi = "10.1136/thoraxjnl-2014-206670",

language = "English",

volume = "70",

pages = "519--527",

journal = "Thorax",

issn = "0040-6376",

publisher = "BMJ Publishing Group",

number = "6",

}

Frith, PA, Thompson, P, Ratnavadivel, R, Chang, CL, Bremner, P, Day, P, Frenzel, C, Kurstjens, N, Waddell, A, Daniel, A, Khoussousi, A, Springfield, A, Veale, A, Graham, AN, Gallagher, B, Pande, BR, O'Kane, B, Jones, C, Baldi, C, Helm, C, O'Dochartaigh, C, Chambers, D, Quinn, D, Yull, D, Karthigesu, D, Then, E, Graham, F, Faigenbaum, F, Geddam, G, Cameron, G, Blom, H, Goldman, H, Snell, H, Chia, I, Jeong, J, Liew, J, Salvaris, J, Pryke, J, Reid, J, Kolbe, J, O'Sullivan, J, Pak, J, Upham, J, Feiber, J, Ford, JOM, Yong, K, Perrin, K, Noonan, L, Atlas, L, Murdoch, L, Pearce, M, Bloch, M, Holmes, M, Chia, M, Epton, M, Leadston, M, Tandon, MK, Chitgopeker, M, Liebenberg, N, Hendry, N, Olaniyi, O, Singh, O, Kendall, P, Van Niekerk, P, Willet, R, Tomlins, R, Pillay, S, Sharifeh, S, Carson, S, Bingham, S, Walford, T, Erasmus, T, Claridge, T & Hess, Z 2015, 'Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: The GLISTEN study - A randomised controlled trial', Thorax, vol. 70, no. 6, pp. 519-527. https://doi.org/10.1136/thoraxjnl-2014-206670

TY - JOUR

T1 - Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: The GLISTEN study - A randomised controlled trial

AU - Frith, P.A.

AU - Thompson, Philip

AU - Ratnavadivel, R.

AU - Chang, C.L.

AU - Bremner, P.

AU - Day, P.

AU - Frenzel, C.

AU - Kurstjens, N.

AU - Waddell, A.

AU - Daniel, A.

AU - Khoussousi, A.

AU - Springfield, A.

AU - Veale, A.

AU - Graham, A.N.

AU - Gallagher, B.

AU - Pande, B.R.

AU - O'Kane, B.

AU - Jones, C.

AU - Baldi, C.

AU - Helm, C.

AU - O'Dochartaigh, C.

AU - Chambers, D.

AU - Quinn, D.

AU - Yull, D.

AU - Karthigesu, D.

AU - Then, E.

AU - Graham, F.

AU - Faigenbaum, F.

AU - Geddam, G.

AU - Cameron, G.

AU - Blom, H.

AU - Goldman, H.

AU - Snell, H.

AU - Chia, I.

AU - Jeong, J.

AU - Liew, J.

AU - Salvaris, J.

AU - Pryke, J.

AU - Reid, J.

AU - Kolbe, J.

AU - O'Sullivan, J.

AU - Pak, J.

AU - Upham, J.

AU - Feiber, J.

AU - Ford, J.O.M.

AU - Yong, K.

AU - Perrin, K.

AU - Noonan, L.

AU - Atlas, L.

AU - Murdoch, L.

AU - Pearce, M.

AU - Bloch, M.

AU - Holmes, M.

AU - Chia, M.

AU - Epton, M.

AU - Leadston, M.

AU - Tandon, M.K.

AU - Chitgopeker, M.

AU - Liebenberg, N.

AU - Hendry, N.

AU - Olaniyi, O.

AU - Singh, O.

AU - Kendall, P.

AU - Van Niekerk, P.

AU - Willet, R.

AU - Tomlins, R.

AU - Pillay, S.

AU - Sharifeh, S.

AU - Carson, S.

AU - Bingham, S.

AU - Walford, T.

AU - Erasmus, T.

AU - Claridge, T.

AU - Hess, Z.

PY - 2015

Y1 - 2015

N2 - Background: The optimal use of various therapeutic combinations for moderate/severe chronic obstructive pulmonary disease (COPD) is unclear. The GLISTEN trial compared the efficacy of two long-acting anti-muscarinic antagonists (LAMA), when combined with an inhaled corticosteroid (ICS) and a long-acting β2 agonist (LABA). Methods: This randomised, blinded, placebo-controlled trial in moderate/severe COPD patients compared once-daily glycopyrronium (GLY) 50 μg, once-daily tiotropium (TIO) 18 μg or placebo (PLA), when combined with salmeterol/fluticasone propionate (SAL/FP) 50/500 μg twice daily. The primary objective was to determine the non-inferiority of GLY+SAL/FP versus TIO+SAL/FP on trough FEV1 after 12 weeks. An important secondary objective was whether addition of GLY to SAL/FP was better than SAL/FP alone. Results: 773 patients (mean FEV1 57.2% predicted) were randomised; 84.9% completed the trial. At week 12, GLY+SAL/FP demonstrated non-inferiority to TIO +SAL/FP for trough FEV1: least square mean treatment difference (LSMdiff) -7 mL (SE 17.4) with a lower limit for non-inferiority of -60 mL. There was significant increase in week 12 trough FEV1 with GLY+SAL/FP versus PLA+SAL/FP (LSMdiff 101 mL, p

AB - Background: The optimal use of various therapeutic combinations for moderate/severe chronic obstructive pulmonary disease (COPD) is unclear. The GLISTEN trial compared the efficacy of two long-acting anti-muscarinic antagonists (LAMA), when combined with an inhaled corticosteroid (ICS) and a long-acting β2 agonist (LABA). Methods: This randomised, blinded, placebo-controlled trial in moderate/severe COPD patients compared once-daily glycopyrronium (GLY) 50 μg, once-daily tiotropium (TIO) 18 μg or placebo (PLA), when combined with salmeterol/fluticasone propionate (SAL/FP) 50/500 μg twice daily. The primary objective was to determine the non-inferiority of GLY+SAL/FP versus TIO+SAL/FP on trough FEV1 after 12 weeks. An important secondary objective was whether addition of GLY to SAL/FP was better than SAL/FP alone. Results: 773 patients (mean FEV1 57.2% predicted) were randomised; 84.9% completed the trial. At week 12, GLY+SAL/FP demonstrated non-inferiority to TIO +SAL/FP for trough FEV1: least square mean treatment difference (LSMdiff) -7 mL (SE 17.4) with a lower limit for non-inferiority of -60 mL. There was significant increase in week 12 trough FEV1 with GLY+SAL/FP versus PLA+SAL/FP (LSMdiff 101 mL, p

U2 - 10.1136/thoraxjnl-2014-206670

DO - 10.1136/thoraxjnl-2014-206670

M3 - Article

SN - 0040-6376

VL - 70

SP - 519

EP - 527

JO - Thorax

JF - Thorax

IS - 6

ER -

Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: The GLISTEN study - A randomised controlled trial

Abstract

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