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 languageEnglish
    Pages (from-to)519-527
    JournalThorax
    Volume70
    Issue number6
    DOIs
    Publication statusPublished - 2015

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