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. Issue 6 (3rd April 2015)

• Record Type: Journal Article
• Authors: Frith, Peter A; Thompson, Philip J; Ratnavadivel, Rajeev; Chang, Catherina L; Bremner, Peter; Day, Peter; Frenzel, Christina; Kurstjens, Nicol
• Other Names: Waddell Ainslie author non-byline.; Daniel Alexander author non-byline.; Khoussousi Alireza author non-byline.; Springfield Andrew author non-byline.; Veale Andrew author non-byline.; Graham Anthony Neil author non-byline.; Gallagher Brad author non-byline.; Pande Braj Raj author non-byline.; O'Kane Brendan author non-byline.; Jones Christopher author non-byline.; Baldi Claudio author non-byline.; Helm Colin author non-byline.; O'Dochartaigh Conor author non-byline.; Chambers Daniel author non-byline.; Quinn Dean author non-byline.; Yull Derek author non-byline.; Karthigesu Dhanalakshi author non-byline.; Then Edward author non-byline.; Graham Frank author non-byline.; Faigenbaum Fred author non-byline.; Geddam Geetha author non-byline.; Cameron Gillian author non-byline.; Blom Hans author non-byline.; Goldman Hershel author non-byline.; Snell Hilary author non-byline.; Chia Imagard author non-byline.; Jeong James author non-byline.; Liew James author non-byline.; Salvaris James author non-byline.; Pryke Jason author non-byline.; Reid Jim author non-byline.; Kolbe John author non-byline.; O'Sullivan John author non-byline.; Pak John author non-byline.; Upham John author non-byline.; Feiber Joseph author non-byline.; Ford Judith O'Malley author non-byline.; Yong Kevin author non-byline.; Perrin Kyle author non-byline.; Noonan Lawrence author non-byline.; Atlas Len author non-byline.; Murdoch Louise author non-byline.; Pearce Margaret author non-byline.; Bloch Mark author non-byline.; Holmes Mark author non-byline.; Chia Michael author non-byline.; Epton Michael author non-byline.; Leadston Michelle author non-byline.; Tandon MK author non-byline.; Chitgopeker Mohan author non-byline.; Liebenberg Naomi author non-byline.; Hendry Neil author non-byline.; Olaniyi Olakunle author non-byline.; Singh Omesh author non-byline.; Kendall Peter author non-byline.; Van Niekerk Peter author non-byline.; Willet Rodney author non-byline.; Tomlins Ronald author non-byline.; Pillay Salven author non-byline.; Sharifeh Sammy author non-byline.; Carson Simon author non-byline.; Bingham Stephen author non-byline.; Walford Ted author non-byline.; Erasmus Tersia author non-byline.; Claridge Trevor author non-byline.; Hess Zofia author non-byline.;
• Is Part Of: Thorax. Volume 70:Issue 6(2015)
• Page Start: 519
• Page End: 527
• Publication Date: 2015-04-03
• Subjects: COPD Pharmacology; Chest -- Diseases -- Periodicals; Thorax; Chest -- Diseases; Periodicals; Periodicals; 617.54
• DOI: 10.1136/thoraxjnl-2014-206670
• Languages: English
• ISSNs: 0040-6376

Abstract

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<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. Trial registration number: NCT01513460.