Please use this identifier to cite or link to this item: https://hdl.handle.net/1/455
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
Authors: Frith, Peter A ;Thompson, Philip ;Ratnavadivel, Rajeev ;Chang, Catherina ;Bremner, Peter ;Day, Peter ;Frenzel, Christina ;Nicol, Kurstjens 
Issue Date: Apr-2015
Source: Volume 70, Issue 6, pp. 519-527
Journal title: Thorax
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.
Description: Open Access: http://thorax.bmj.com/content/70/6/519.short
URI: https://elibrary.cclhd.health.nsw.gov.au/cclhdjspui/community-list/handle/1/455
DOI: 10.1136/thoraxjnl-2014-206670
Pubmed: http://www.ncbi.nlm.nih.gov/pubmed/25841237
ISSN: 1468-3296
Publicaton type: Journal Article
Keywords: Respiratory
Drug Therapy
Study or Trial: Randomized Controlled Clinical Trial/Controlled Clinical Trial
Appears in Collections:Respiratory

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