A randomised, open-label study of umeclidinium versus glycopyrronium in patients with COPD

ERJ Open Research

Volumn 2, Issue 2, 2016, Pages

  Rheault, Tara ^a   Khindri, Sanjeev ^b   Vahdati Bolouri, Mitra ^b   Church, Alison ^a   Fahy, William A ^b  

^a GLAXOSMITHKLINE   (United States)

^b GLAXOSMITHKLINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85016593560     PISSN: None     EISSN: 23120541     Source Type: Journal    
DOI: 10.1183/23120541.00101-2015     Document Type: Article

References (31)

1. Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2015. www.goldcopd.org/Date last updated: 2015. Date last accessed: August 10, 2015.
2. Boehringer-Ingelheim. SPIRIVA. Prescribing Information. http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt& folderPath=/Prescribing+Information/PIs/Spiriva/Spiriva.pdf Date last updated: 2014. Date last accessed: September 3, 2015.
3. Novartis. Seebri Breezhaler. Summary of product characteristics. www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002430/WC500133769.pdf Date last updated: 2015. Date last accessed: September 5, 2015.
4. Novartis. Seebri Neohaler. Prescribing information. www.accessdata.fda.gov/drugsatfda_docs/label/2015/207923lbl.pdf Date last updated: 2015. Date last accessed: November 6, 2015.
5. GlaxoSmithKline. INCRUSE. Summary of product characteristics. www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002809/human_med_001755.jsp& mid=WC0b01ac058001d124 Date last updated: 2015. Date last accessed: September 3, 2015.
6. GlaxoSmithKline. INCRUSE. Prescribing information. www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Incruse_Ellipta/pdf/INCRUSE-ELLIPTA-PI-PIL.PDF Date last updated: 2014. Date last accessed: September 3, 2015.
7. AstraZeneca. Eklira Genuair. Summary of product characteristics. www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002211/WC500132661.pdf Date last updated: 2015. Date last accessed: September 9, 2015.
8. Almirall. Tudorza Pressair. Prescribing information. www.accessdata.fda.gov/drugsatfda_docs/label/2012/202450s000lbl.pdf Date last updated: 2012. Date last accessed: October 28, 2015.
9. Boehringer-Ingelheim. SPIRIVA. Summary of product characteristics. www.medicines.org.uk/emc/medicine/20134l. Date last updated: 2014. Date last accessed: October 29, 2015.
10. Chapman KR, Beeh KM, Beier J, et al. A blinded evaluation of the efficacy and safety of glycopyrronium, a once-daily long-acting muscarinic antagonist, versus tiotropium, in patients with COPD: the GLOW5 study. BMC Pulm Med 2014; 14: 4.
11. Riario-Sforza GG, Ridolo E, Riario-Sforza E, et al. Glycopyrronium bromide for the treatment of chronic obstructive pulmonary disease. Expert Rev Respir Med 2015; 9: 23-33.
12. Cope S, Donohue JF, Jansen JP, et al. Comparative efficacy of long-acting bronchodilators for COPD: a network meta-analysis. Respir Res 2013; 14: 100.
13. Karabis A, Lindner L, Mocarski M, et al. Comparative efficacy of aclidinium versus glycopyrronium and tiotropium, as maintenance treatment of moderate to severe COPD patients: a systematic review and network meta-analysis. Int J Chron Obstruct Pulmon Dis 2013; 8: 405-423.
14. Ismaila AS, Huisman EL, Punekar YS, et al. Comparative efficacy of long-acting muscarinic antagonist monotherapies in COPD: a systematic review and network meta-analysis. Int J Chron Obstruct Pulmon Dis 2015; 10: 2495-2517.
15. Segreti A, Calzetta L, Rogliani P, et al. Umeclidinium for the treatment of chronic obstructive pulmonary disease. Expert Rev Respir Med 2014; 8: 665-671.
16. Donohue JF, Anzueto A, Brooks J, et al. A randomized, double-blind dose-ranging study of the novel LAMA GSK573719 in patients with COPD. Respir Med 2012; 106: 970-979.
17. Trivedi R, Richard N, Mehta R, et al. Umeclidinium in patients with COPD: a randomised, placebo-controlled study. Eur Respir J 2014; 43: 72-81.
18. D’Urzo A, Ferguson GT, van Noord JA, et al. Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial. Respir Res 2011; 12: 156.
19. Fogarty C, Hattersley H, Di Scala L, et al. Bronchodilatory effects of NVA237, a once daily long-acting muscarinic antagonist, in COPD patients. Respir Med 2011; 105: 337-342.
20. Kerwin E, Hebert J, Gallagher N, et al. Efficacy and safety of NVA237 versus placebo and tiotropium in patients with COPD: the GLOW2 study. Eur Respir J 2012; 40: 1106-1114.
21. Celli BR, MacNee W. Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ ERS position paper. Eur Respir J 2004; 23: 932-946.
22. Mahler DA, Witek TJ Jr. The MCID of the transition dyspnea index is a total score of one unit. COPD 2005; 2: 99-103.
23. Jones PW. St. George’s Respiratory Questionnaire: MCID. COPD 2005; 2: 75-79.
24. Kon SS, Canavan JL, Jones SE, et al. Minimum clinically important difference for the COPD Assessment Test: a prospective analysis. Lancet Respir Med 2014; 2: 195-203.
25. Donohue JF. Minimal clinically important differences in COPD lung function. COPD 2005; 2: 111-124.
26. Snapinn SM. Noninferiority trials. Curr Control Trials Cardiovasc Med 2000; 1: 19-21.
27. Lewis JA, Machin D. Intention to treat: who should use ITT? Br J Cancer 1993; 68: 647-650.
28. Witek TJ Jr, Mahler DA. Meaningful effect size and patterns of response of the transition dyspnea index. J Clin Epidemiol 2003; 56: 248-255.
29. Witek TJ Jr, Mahler DA. Minimal important difference of the transition dyspnoea index in a multinational clinical trial. Eur Respir J 2003; 21: 267-272.
30. Jones PW, Harding G, Berry P, et al. Development and first validation of the COPD Assessment Test. Eur Respir J 2009; 34: 648-654.
31. Rennard S, Fogarty C, Reisner C, et al. Randomized study of the safety, pharmacokinetics, and bronchodilatory efficacy of a proprietary glycopyrronium metered-dose inhaler in study patients with chronic obstructive pulmonary disease. BMC Pulm Med 2014; 14: 118.