BACKGROUND: Single inhaler triple therapies providing an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta2-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 320/18/9.6mug and 160/18/9.6mug) will be compared to glycopyrrolate/formoterol fumarate (GFF) MDI 18/9.6mug and budesonide/formoterol fumarate (BFF) MDI 320/9.6mug, 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/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.
- Rabe, K. F.
- Martinez, F. J.
- Ferguson, G. T.
- Wang, C.
- Singh, D.
- Wedzicha, J. A.
- Trivedi, R.
- St Rose, E.
- Ballal, S.
- McLaren, J.
- Darken, P.
- Reisner, C.
- Dorinsky, P.
Keywords
- *bgf mdi
- *Chronic obstructive pulmonary disease
- *Exacerbations
- *Inhaled corticosteroid
- *Study protocol
- *Triple therapy