BibTex format
@article{Rabe:2019:10.1016/j.rmed.2019.08.010,
author = {Rabe, KF and Martinez, FJ and Ferguson, GT and Wang, C and Singh, D and Wedzicha, JA and Trivedi, R and St, Rose E and Ballal, S and McLaren, J and Darken, P and Reisner, C and Dorinsky, P},
doi = {10.1016/j.rmed.2019.08.010},
journal = {Respiratory Medicine},
pages = {59--66},
title = {A phase III study of triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler 320/18/9.6μg and 160/18/9.6μg using co-suspension delivery technology in moderate-to-very severe COPD: The ETHOS study protocol},
url = {http://dx.doi.org/10.1016/j.rmed.2019.08.010},
volume = {158},
year = {2019}
}
RIS format (EndNote, RefMan)
TY - JOUR
AB - BACKGROUND: Single inhaler triple therapies providing an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting β2-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 320/18/9.6μg and 160/18/9.6μg) will be compared to glycopyrrolate/formoterol fumarate (GFF) MDI 18/9.6μg and budesonide/formoterol fumarate (BFF) MDI 320/9.6μg, 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 ≥150cells/mm3. 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.
AU - Rabe,KF
AU - Martinez,FJ
AU - Ferguson,GT
AU - Wang,C
AU - Singh,D
AU - Wedzicha,JA
AU - Trivedi,R
AU - St,Rose E
AU - Ballal,S
AU - McLaren,J
AU - Darken,P
AU - Reisner,C
AU - Dorinsky,P
DO - 10.1016/j.rmed.2019.08.010
EP - 66
PY - 2019///
SN - 0954-6111
SP - 59
TI - A phase III study of triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler 320/18/9.6μg and 160/18/9.6μg using co-suspension delivery technology in moderate-to-very severe COPD: The ETHOS study protocol
T2 - Respiratory Medicine
UR - http://dx.doi.org/10.1016/j.rmed.2019.08.010
UR - https://www.ncbi.nlm.nih.gov/pubmed/31605923
UR - http://hdl.handle.net/10044/1/74088
VL - 158
ER -