Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)

Summary

This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate to very severe COPD.

Timeline

Start

2015-06-30

Primary completion

2019-07-26

Completion

2019-07-26

Outcome

Met primary endpoint

registry analysis (superiority test); BGF MDI 320/14.4/9.6 μg vs GFF MDI 14.4/9.6 μg; p <0.0001; Rate Ratio 0.76 (95% CI 0.69 to 0.83) NCT02465567 ↗

paper The rate was significantly lower with 320-μg-budesonide triple therapy than with glycopyrrolate-formoterol PMID 32579807 ↗

release “ETHOS trial in which Breztri Aerosphere , a triple-combination therapy, showed a statistically significant reduction in the rate of moderate or severe exacerbations” astrazeneca.com ↗

Publications

• Deslee G, Russo H, Fabry-Vendrand C, Koskas D, Thabut G, Bell JP, Caplen M, Bhatt PD, Carioto J, Pyenson B, Burgel PR. Impact of Increased Use of Single-Inhaler Triple Therapies on COPD Exacerbation Rates, Mortality, and Total Costs: PROMETHEUS France. Int J Chron Obstruct Pulmon Dis. 2025 Nov 17;20:3753-3763. doi: 10.2147/COPD.S539055. eCollection 2025.
• Muro S, Seki M, Hurst JR, Petullo D, Marshall J, Bowen K, Darken PF, Duncan EA, Megally A, Patel M. Triple Therapy with Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate versus Dual Therapies for Patients with COPD and Phenotypic Features of Asthma: A Pooled Post Hoc Analysis of KRONOS and ETHOS. Int J Chron Obstruct Pulmon Dis. 2024 Dec 12;19:2729-2737. doi: 10.2147/COPD.S478349. eCollection 2024.
• Singh D, Martinez FJ, Hurst JR, Han MK, Gale CP, Fredriksson M, Kisielewicz D, Mushunje A, Movitz C, Ojili N, Parikh H, Arya N, Bowen K, Patel M. Effect of Triple Therapy on Cardiovascular and Severe Cardiopulmonary Events in Chronic Obstructive Pulmonary Disease: A Post Hoc Analysis of a Randomized, Double-Blind, Phase 3 Clinical Trial (ETHOS). Am J Respir Crit Care Med. 2025 Feb;211(2):205-214. doi: 10.1164/rccm.202312-2311OC.
• Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314.
• Rhodes K, Jenkins M, de Nigris E, Aurivillius M, Ouwens M. Relationship between risk, cumulative burden of exacerbations and mortality in patients with COPD: modelling analysis using data from the ETHOS study. BMC Med Res Methodol. 2022 May 25;22(1):150. doi: 10.1186/s12874-022-01616-7.
• Rabe KF, Martinez FJ, Ferguson GT, Wang C, Singh D, Wedzicha JA, Trivedi R, St Rose E, Ballal S, McLaren J, Darken P, Aurivillius M, Reisner C, Dorinsky P; ETHOS Investigators. Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD. N Engl J Med. 2020 Jul 2;383(1):35-48. doi: 10.1056/NEJMoa1916046. Epub 2020 Jun 24.
• Rabe KF, Martinez FJ, Ferguson GT, Wang C, Singh D, Wedzicha JA, Trivedi R, St Rose E, Ballal S, McLaren J, Darken P, Reisner C, Dorinsky P. A phase III study of triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler 320/18/9.6 mug and 160/18/9.6 mug using co-suspension delivery technology in moderate-to-very severe COPD: The ETHOS study protocol. Respir Med. 2019 Oct-Nov;158:59-66. doi: 10.1016/j.rmed.2019.08.010. Epub 2019 Aug 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Budesonide	Small molecule	160 ug	Inhaled
Subject	Budesonide	Small molecule	320 ug	Inhaled
Subject	Glycopyrronium	Unknown	14.4 ug	Inhaled
Background	Formoterol	Other / unclassified	9.6 ug	Inhaled

Indications