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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 2015; 70(6):519-27T

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.

Authors+Show Affiliations

Respiratory Clinical Research Unit, Repatriation General Hospital, Adelaide, South Australia, Australia.The Lung Health Clinic, Centre for Asthma Allergy and Respiratory Research, University of Western Australia, and the Lung Institute of Western Australia, Perth, Western Australia, Australia.Department of Respiratory Medicine, Gosford Hospital, Gosford, New South Wales, Australia.Department of Respiratory and Sleep Medicine, Waikato Hospital, Hamilton, New Zealand.St John of God Hospital, Murdoch, Western Australia, Australia.Medical Centre, Redcliffe Peninsula 7 Day Medical Centre, Brisbane, Queensland, Australia.Clinical Development and Medical Affairs, Novartis Pharmaceuticals Australia Pty Limited, Sydney, New South Wales, Australia.Clinical Development and Medical Affairs, Novartis Pharmaceuticals Australia Pty Limited, Sydney, New South Wales, Australia.No affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25841237

Citation

Frith, Peter A., et al. "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, 2015, pp. 519-27.
Frith PA, Thompson PJ, Ratnavadivel R, et al. 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. 2015;70(6):519-27.
Frith, P. A., Thompson, P. J., Ratnavadivel, R., Chang, C. L., Bremner, P., Day, P., ... Kurstjens, N. (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), pp. 519-27. doi:10.1136/thoraxjnl-2014-206670.
Frith PA, et al. 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. 2015;70(6):519-27. PubMed PMID: 25841237.
* Article titles in AMA citation format should be in sentence-case
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,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 - ,, Y1 - 2015/04/03/ PY - 2014/12/09/received PY - 2015/03/19/accepted PY - 2015/4/5/entrez PY - 2015/4/5/pubmed PY - 2015/9/5/medline KW - COPD Pharmacology SP - 519 EP - 27 JF - Thorax JO - Thorax VL - 70 IS - 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. TRIAL REGISTRATION NUMBER: NCT01513460. SN - 1468-3296 UR - https://www.unboundmedicine.com/medline/citation/25841237/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_ L2 - http://thorax.bmj.com/cgi/pmidlookup?view=long&amp;pmid=25841237 DB - PRIME DP - Unbound Medicine ER -