TY - JOUR
T1 - Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD
T2 - The GLISTEN study - A randomised controlled trial
AU - Frith, Peter A.
AU - Thompson, Philip J.
AU - Ratnavadivel, Rajeev
AU - Chang, Catherina L.
AU - Bremner, Peter
AU - Day, Peter
AU - Frenzel, Christina
AU - Kurstjens, Nicol
AU - Glisten Study Group
AU - Waddell, Ainslie
AU - Daniel, Alexander
AU - Khoussousi, Alireza
AU - Springfield, Andrew
AU - Veale, Andrew
AU - Graham, Anthony Neil
AU - Gallagher, Brad
AU - Pande, Braj Raj
AU - O'Kane, Brendan
AU - Jones, Christopher
AU - Baldi, Claudio
AU - Helm, Colin
AU - O'Dochartaigh, Conor
AU - Chambers, Daniel
AU - Quinn, Dean
AU - Yull, Derek
AU - Karthigesu, Dhanalakshi
AU - Then, Edward
AU - Graham, Frank
AU - Faigenbaum, Fred
AU - Geddam, Geetha
AU - Cameron, Gillian
AU - Blom, Hans
AU - Goldman, Hershel
AU - Snell, Hilary
AU - Chia, Imagard
AU - Jeong, James
AU - Liew, James
AU - Salvaris, James
AU - Pryke, Jason
AU - Reid, Jim
AU - Kolbe, John
AU - O'Sullivan, John
AU - Pak, John
AU - Upham, John
AU - Feiber, Joseph
AU - Ford, Judith O.Malley
AU - Yong, Kevin
AU - Perrin, Kyle
AU - Noonan, Lawrence
AU - Atlas, Len
AU - Murdoch, Louise
AU - Pearce, Margaret
AU - Bloch, Mark
AU - Holmes, Mark
AU - Chia, Michael
AU - Epton, Michael
AU - Leadston, Michelle
AU - Tandon, M. K.
AU - Chitgopeker, Mohan
AU - Liebenberg, Naomi
AU - Hendry, Neil
AU - Olaniyi, Olakunle
AU - Singh, Omesh
AU - Kendall, Peter
AU - Van Niekerk, Peter
AU - Willet, Rodney
AU - Tomlins, Ronald
AU - Pillay, Salven
AU - Sharifeh, Sammy
AU - Carson, Simon
AU - Bingham, Stephen
AU - Walford, Ted
AU - Erasmus, Tersia
AU - Claridge, Trevor
AU - Hess, Zofia
N1 - This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
PY - 2015/6
Y1 - 2015/6
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<0.001). At 12 weeks, GLY+SAL/FP produced significant improvement in St. George's Respiratory Questionnaire total score versus PLA +SAL/FP (LSMdiff -2.154, p=0.02). GLY+SAL/FP demonstrated significant rescue medication reduction versus PLA+SAL/FP (LSMdiff -0.72 puffs/day, p<0.001). Serious adverse events were similar for GLY+SAL/FP, TIO +SAL/FP and PLA+SAL/FP with an incidence of 5.8%, 8.5% and 5.8%, respectively. Conclusions: GLY+SAL/FP showed comparable improvements in lung function, health status and rescue medication to TIO+SAL/FP. Importantly, addition of GLY to SAL/FP demonstrated significant improvements in lung function, health status and rescue medication compared to SAL/FP.
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<0.001). At 12 weeks, GLY+SAL/FP produced significant improvement in St. George's Respiratory Questionnaire total score versus PLA +SAL/FP (LSMdiff -2.154, p=0.02). GLY+SAL/FP demonstrated significant rescue medication reduction versus PLA+SAL/FP (LSMdiff -0.72 puffs/day, p<0.001). Serious adverse events were similar for GLY+SAL/FP, TIO +SAL/FP and PLA+SAL/FP with an incidence of 5.8%, 8.5% and 5.8%, respectively. Conclusions: GLY+SAL/FP showed comparable improvements in lung function, health status and rescue medication to TIO+SAL/FP. Importantly, addition of GLY to SAL/FP demonstrated significant improvements in lung function, health status and rescue medication compared to SAL/FP.
KW - COPD
KW - LAMA
KW - inhaled corticosteroid (ICS)
UR - http://www.scopus.com/inward/record.url?scp=84933524786&partnerID=8YFLogxK
U2 - 10.1136/thoraxjnl-2014-206670
DO - 10.1136/thoraxjnl-2014-206670
M3 - Article
C2 - 25841237
AN - SCOPUS:84933524786
SN - 0040-6376
VL - 70
SP - 519
EP - 527
JO - Thorax
JF - Thorax
IS - 6
ER -