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

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dc.contributor.authorChapman, Kenneth R
dc.contributor.authorBeeh, Kai-Michael
dc.contributor.authorBeier, Jutta
dc.contributor.authorBateman, Eric D
dc.contributor.authorD’Urzo, Anthony
dc.contributor.authorNutbrown, Robert
dc.contributor.authorHenley, Michelle
dc.contributor.authorChen, Hungta
dc.contributor.authorOverend, Tim
dc.contributor.authorD’Andrea, Peter
dc.date.accessioned2015-03-04T09:48:13Z
dc.date.available2015-03-04T09:48:13Z
dc.date.issued2014-01-17
dc.date.updated2015-01-15T17:52:35Z
dc.description.abstractAbstract Background Two once-daily long-acting muscarinic antagonists (LAMAs) are currently available for the treatment of chronic obstructive pulmonary disease (COPD) – tiotropium and glycopyrronium. Previous studies have compared glycopyrronium with open-label tiotropium. In the GLOW5 study, we compare glycopyrronium with blinded tiotropium. Methods In this blinded, double-dummy, parallel group, 12-week study, patients with moderate-to-severe COPD were randomized 1:1 to glycopyrronium 50 μg once daily or tiotropium 18 μg once daily. The primary objective was to demonstrate the non-inferiority of glycopyrronium versus blinded tiotropium with respect to trough forced expiratory volume in 1 second (FEV1) following 12 weeks of treatment (non-inferiority margin: –50 mL). Secondary objectives were to evaluate glycopyrronium versus tiotropium for other spirometric outcomes, breathlessness (Transition Dyspnea Index; TDI), health status (St George’s Respiratory Questionnaire; SGRQ), daily rescue medication use, COPD exacerbations and COPD symptoms over 12 weeks of treatment. Results 657 patients were randomized (glycopyrronium: 327; tiotropium: 330); 96% (630 patients) completed the study. Least squares mean trough FEV1 for both glycopyrronium and tiotropium was 1.405 L at Week 12, meeting the criterion for non-inferiority (mean treatment difference: 0 mL, 95% CI: –32, 31 mL). Glycopyrronium demonstrated rapid bronchodilation following first dose on Day 1, with significantly higher FEV1 at all time points from 0–4 h post-dose versus tiotropium (all p < 0.001). FEV1 area under the curve from 0–4 h (AUC0–4h) post-dose with glycopyrronium was significantly superior to tiotropium on Day 1 (p < 0.001) and was comparable to tiotropium at Week 12. Glycopyrronium demonstrated comparable improvements to tiotropium in TDI focal score, SGRQ total score, rescue medication use and the rate of COPD exacerbations (all p = not significant). Patients on glycopyrronium also had a significantly lower total COPD symptom score versus patients on tiotropium after 12 weeks (p = 0.035). Adverse events were reported by a similar percentage of patients receiving glycopyrronium (40.4%) and tiotropium (40.6%). Conclusion In patients with moderate-to-severe COPD, 12-week blinded treatment with once-daily glycopyrronium 50 μg or tiotropium 18 μg, provided similar efficacy and safety, with glycopyrronium having a faster onset of action on Day 1 versus tiotropium. Trial registration ClinicalTrial.gov, NCT01613326en_ZA
dc.identifier.apacitationChapman, K. R., Beeh, K., Beier, J., Bateman, E. D., , Nutbrown, R., ... (2014). 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. <i>BMC Pulmonary Medicine</i>, http://hdl.handle.net/11427/12553en_ZA
dc.identifier.chicagocitationChapman, Kenneth R, Kai-Michael Beeh, Jutta Beier, Eric D Bateman, , Robert Nutbrown, Michelle Henley, Hungta Chen, Tim Overend, and "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." <i>BMC Pulmonary Medicine</i> (2014) http://hdl.handle.net/11427/12553en_ZA
dc.identifier.citationChapman, K. R., Beeh, K. M., Beier, J., Bateman, E. D., D’Urzo, A., Nutbrown, R., ... and D’Andrea, P. (2014). 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 pulmonary medicine, 14(1), 4.en_ZA
dc.identifier.issn1471-2466
dc.identifier.ris TY - Journal Article AU - Chapman, Kenneth R AU - Beeh, Kai-Michael AU - Beier, Jutta AU - Bateman, Eric D AU - D’Urzo, Anthony AU - Nutbrown, Robert AU - Henley, Michelle AU - Chen, Hungta AU - Overend, Tim AU - D’Andrea, Peter AB - Abstract Background Two once-daily long-acting muscarinic antagonists (LAMAs) are currently available for the treatment of chronic obstructive pulmonary disease (COPD) – tiotropium and glycopyrronium. Previous studies have compared glycopyrronium with open-label tiotropium. In the GLOW5 study, we compare glycopyrronium with blinded tiotropium. Methods In this blinded, double-dummy, parallel group, 12-week study, patients with moderate-to-severe COPD were randomized 1:1 to glycopyrronium 50 μg once daily or tiotropium 18 μg once daily. The primary objective was to demonstrate the non-inferiority of glycopyrronium versus blinded tiotropium with respect to trough forced expiratory volume in 1 second (FEV1) following 12 weeks of treatment (non-inferiority margin: –50 mL). Secondary objectives were to evaluate glycopyrronium versus tiotropium for other spirometric outcomes, breathlessness (Transition Dyspnea Index; TDI), health status (St George’s Respiratory Questionnaire; SGRQ), daily rescue medication use, COPD exacerbations and COPD symptoms over 12 weeks of treatment. Results 657 patients were randomized (glycopyrronium: 327; tiotropium: 330); 96% (630 patients) completed the study. Least squares mean trough FEV1 for both glycopyrronium and tiotropium was 1.405 L at Week 12, meeting the criterion for non-inferiority (mean treatment difference: 0 mL, 95% CI: –32, 31 mL). Glycopyrronium demonstrated rapid bronchodilation following first dose on Day 1, with significantly higher FEV1 at all time points from 0–4 h post-dose versus tiotropium (all p < 0.001). FEV1 area under the curve from 0–4 h (AUC0–4h) post-dose with glycopyrronium was significantly superior to tiotropium on Day 1 (p < 0.001) and was comparable to tiotropium at Week 12. Glycopyrronium demonstrated comparable improvements to tiotropium in TDI focal score, SGRQ total score, rescue medication use and the rate of COPD exacerbations (all p = not significant). Patients on glycopyrronium also had a significantly lower total COPD symptom score versus patients on tiotropium after 12 weeks (p = 0.035). Adverse events were reported by a similar percentage of patients receiving glycopyrronium (40.4%) and tiotropium (40.6%). Conclusion In patients with moderate-to-severe COPD, 12-week blinded treatment with once-daily glycopyrronium 50 μg or tiotropium 18 μg, provided similar efficacy and safety, with glycopyrronium having a faster onset of action on Day 1 versus tiotropium. Trial registration ClinicalTrial.gov, NCT01613326 DA - 2014-01-17 DB - OpenUCT DO - 10.1186/1471-2466-14-4 DP - University of Cape Town J1 - BMC Pulmonary Medicine LK - https://open.uct.ac.za PB - University of Cape Town PY - 2014 SM - 1471-2466 T1 - 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 TI - 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 UR - http://hdl.handle.net/11427/12553 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/12553
dc.identifier.urihttp://dx.doi.org/10.1186/1471-2466-14-4
dc.identifier.vancouvercitationChapman KR, Beeh K, Beier J, Bateman ED, , Nutbrown R, 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 Pulmonary Medicine. 2014; http://hdl.handle.net/11427/12553.en_ZA
dc.languageengen_ZA
dc.language.rfc3066en
dc.publisherBioMed Centralen_ZA
dc.publisher.departmentDepartment of Medicineen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsCreative Commons Attribution 4.0 International (CC BY 4.0)*
dc.rights.holderChapman et al.; licensee BioMed Central Ltd.
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_ZA
dc.sourceBMC Pulmonary Medicineen_ZA
dc.source.urihttp://www.biomedcentral.com/bmcpulmmed/
dc.subject.otherCOPDen_ZA
dc.subject.otherGlycopyrroniumen_ZA
dc.subject.otherBreezhaleren_ZA
dc.subject.otherTiotropiumen_ZA
dc.titleA blinded evaluation of the efficacy and safety of glycopyrronium, a once-daily long-acting muscarinic antagonist, versus tiotropium, in patients with COPD: the GLOW5 studyen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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