A phase III study of triple therapy with budesonide/glycopyrrolate/ formoterol fumarate metered dose inhaler 320/18/9.6 mu g and 160/18/9.6 mu g using co-suspension delivery technology in moderate-to-very severe COPD: The ETHOS study protocol
单位：[1]LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany[2]Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York, NY, USA[3]Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA[4]National Clinical Research Centre for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China[5]Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester, UK[6]Respiratory Division, National Heart and Lung Institute, London, UK[7]AstraZeneca, Durham, NC, USA[8]AstraZeneca, Morristown, NJ, USA[9]AstraZeneca, Gaithersburg, MD, USA
Background: Single inhaler triple therapies providing an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta(2)-agonist (ICS/LAMA/LABAs) are an emerging treatment option for chronic obstructive pulmonary disease (COPD). Nevertheless, questions remain regarding the optimal patient population for triple therapy as well as the benefit:risk ratio of ICS treatment. Methods: ETHOS is an ongoing, randomized, double-blind, multicenter, parallel-group, 52-week study in symptomatic patients with moderate-to-very severe COPD and a history of exacerbation(s) in the previous year. Two doses of single inhaler triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI 320/18/9.6 mu g and 160/18/9.6 mu g) will be compared to glycopyrrolate/formoterol fumarate (GFF) MDI 18/9.6 mu g and budesonide/formoterol fumarate (BFF) MDI 320/9.6 mu g, all formulated using co-suspension delivery technology. Outcomes include the rate of moderate/severe (primary endpoint) and severe COPD exacerbations, symptoms, quality of life, and all-cause mortality. Sub-studies will assess lung function and cardiovascular safety. Study population: From June 2015-July 2018, 16,044 patients were screened and 8572 were randomized. Preliminary baseline demographics show that 55.9% of patients had experienced >= 2 moderate/severe exacerbations in the previous year, 79.1% were receiving an ICS-containing treatment at study entry, and 59.9% had blood eosinophil counts >= 150 cells/mm(3). Conclusions: ETHOS will provide data on exacerbations, patient-reported outcomes, mortality, and safety in 8572 patients with moderate-to-very severe COPD receiving triple and dual fixed-dose combinations. For the first time, ICS/LAMA/LABA triple therapy with two different doses of ICS will be compared to dual ICS/LABA and LAMA/LABA therapies.
基金：
AstraZeneca, Cambridge, UKAstraZeneca; MRCUK Research & Innovation (UKRI)Medical Research Council UK (MRC) [G0800570, G1001372, G1001365] Funding Source: UKRI
语种：
外文
被引次数：
WOS：
中科院(CAS)分区：
出版当年[2018]版：
大类|3 区医学
小类|3 区心脏和心血管系统3 区呼吸系统
最新[2025]版：
大类|3 区医学
小类|3 区心脏和心血管系统3 区呼吸系统
JCR分区：
出版当年[2017]版：
Q2RESPIRATORY SYSTEMQ2CARDIAC & CARDIOVASCULAR SYSTEMS
最新[2023]版：
Q2CARDIAC & CARDIOVASCULAR SYSTEMSQ2RESPIRATORY SYSTEM
第一作者单位：[1]LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany[*1]LungenClinic Grosshansdorf, Wöhrendamm 80, 22927, Großhansdorf, Germany
通讯作者：
通讯机构：[1]LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany[*1]LungenClinic Grosshansdorf, Wöhrendamm 80, 22927, Großhansdorf, Germany
推荐引用方式(GB/T 7714)：
Rabe Klaus F.,Martinez Fernando J.,Ferguson Gary T.,et al.A phase III study of triple therapy with budesonide/glycopyrrolate/ formoterol fumarate metered dose inhaler 320/18/9.6 mu g and 160/18/9.6 mu g using co-suspension delivery technology in moderate-to-very severe COPD: The ETHOS study protocol[J].RESPIRATORY MEDICINE.2019,158:59-66.doi:10.1016/j.rmed.2019.08.010.
APA：
Rabe, Klaus F.,Martinez, Fernando J.,Ferguson, Gary T.,Wang, Chen,Singh, Dave...&Dorinsky, Paul.(2019).A phase III study of triple therapy with budesonide/glycopyrrolate/ formoterol fumarate metered dose inhaler 320/18/9.6 mu g and 160/18/9.6 mu g using co-suspension delivery technology in moderate-to-very severe COPD: The ETHOS study protocol.RESPIRATORY MEDICINE,158,
MLA：
Rabe, Klaus F.,et al."A phase III study of triple therapy with budesonide/glycopyrrolate/ formoterol fumarate metered dose inhaler 320/18/9.6 mu g and 160/18/9.6 mu g using co-suspension delivery technology in moderate-to-very severe COPD: The ETHOS study protocol".RESPIRATORY MEDICINE 158.(2019):59-66
