A phase III study of triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler 320/18/9.6 μg and 160/18/9.6 μg using co-suspension delivery technology in moderate-to-very severe COPD: The ETHOS study protocol.

Autor: Rabe KF; LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany. Electronic address: k.f.rabe@lungenclinic.de., Martinez FJ; Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York, NY, USA., Ferguson GT; Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA., Wang C; National Clinical Research Centre for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China., Singh D; Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester, UK., Wedzicha JA; Respiratory Division, National Heart and Lung Institute, London, UK., Trivedi R; AstraZeneca, Durham, NC, USA., St Rose E; AstraZeneca, Morristown, NJ, USA., Ballal S; AstraZeneca, Morristown, NJ, USA., McLaren J; AstraZeneca, Gaithersburg, MD, USA., Darken P; AstraZeneca, Morristown, NJ, USA., Reisner C; AstraZeneca, Morristown, NJ, USA., Dorinsky P; AstraZeneca, Durham, NC, USA.
Jazyk: angličtina
Zdroj: Respiratory medicine [Respir Med] 2019 Oct - Nov; Vol. 158, pp. 59-66. Date of Electronic Publication: 2019 Aug 22.
DOI: 10.1016/j.rmed.2019.08.010
Abstrakt: Background: Single inhaler triple therapies providing an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting β 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 μg and 160/18/9.6 μg) will be compared to glycopyrrolate/formoterol fumarate (GFF) MDI 18/9.6 μg and budesonide/formoterol fumarate (BFF) MDI 320/9.6 μg, 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.
Clinical Trial Registration Number: NCT02465567.
(Copyright © 2019. Published by Elsevier Ltd.)
Databáze: MEDLINE
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