WILMINGTON, Del. — AstraZeneca today announced the initiation of a Phase III trial to investigate the potential effect of triple-combination inhaled therapy BREZTRI AEROSPHERE® (budesonide/glycopyrronium/formoterol fumarate, or BGF) on severe cardiopulmonary outcomes, including death*, in people with chronic obstructive pulmonary disease (COPD) who also have elevated cardiopulmonary risk, irrespective of their exacerbation history.
Also, the first participants have been dosed in ATHLOS, a Phase III trial investigating AstraZeneca’s triple therapy BGF vs. ICS/LABA budesonide/formoterol fumarate (BFF) or placebo on cardiopulmonary parameters including hyperinflation and exercise endurance time, which are associated with health status and survival.
COPD impacts 391 million people globally. The disease’s mechanisms elevate the risk of both pulmonary and cardiac events, including severe or fatal COPD exacerbations and cardiac events, which is termed cardiopulmonary risk. This underlying risk is further increased after a COPD exacerbation and may remain elevated for up to a year following an exacerbation. Just one COPD exacerbation doubles the risk of a heart attack and increases risk of hospitalization and cardiopulmonary-related death. Cardiopulmonary causes are the most common reasons for death in patients with COPD.
Fernando Martinez, MD, MS, Chief of the Division of Pulmonary and Critical Care Medicine at Weill Cornell Medicine and New York-Presbyterian Hospital, and International Co-ordinating Investigator in the THARROS trial said, “The 2024 GOLD Report highlights the treatment effect of non-pharmacologic interventions and inhaled triple combination therapies on mortality. The Report calls for a more proactive therapeutic approach to improve outcomes in COPD. If positive, the THARROS trial will provide critical evidence about the potential of single inhaler, triple combination therapy to reduce severe cardiopulmonary events and further advance treatment goals in COPD, including for patients with no history of exacerbations, for whom no evidence currently exists.”
David Berg MD, MPH, Associate Physician in Cardiovascular and Critical Care Medicine, Brigham and Women’s Hospital, Harvard Medical School, US added: “Large outcomes trials have transformed the management of cardiovascular diseases by enhancing our understanding of the potentially broad impact of therapies targeting those diseases. Current evidence already supports a proactive treatment approach in COPD. Now THARROS is seeking to provide first-of-its-kind evidence to support a strategy of comprehensive cardiopulmonary risk reduction with a triple therapy.”
Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “We have an important and urgent mission to eliminate COPD as a leading cause of death. Even moderate COPD exacerbations are associated with increased risks of further lung events, severe cardiovascular complications and have been shown to contribute to patients dying. With the first-of-its-kind THARROS study, we aim to demonstrate the potential of triple therapy to address cardiopulmonary risk.”
BGF is approved to treat COPD in 75 countries worldwide including the US, EU, China and Japan.
* The severe cardiopulmonary outcome measures investigated in THARROS include death from respiratory and cardiac causes.
About COPD
COPD refers to a group of lung diseases, including chronic bronchitis and emphysema, that cause airflow blockage and breathing-related problems. Affecting an estimated 16 million Americans, COPD is the third leading cause of death due to chronic disease and the sixth overall leading cause of death in the US.
About BREZTRI AEROSPHERE®
BREZTRI AEROSPHERE (budesonide/glycopyrronium/formoterol fumarate) is a single-inhaler, fixed-dose triple-combination of formoterol fumarate, a LABA, glycopyrronium bromide, a LAMA, with budesonide, an ICS, and delivered in a pressurized metered-dose inhaler. BREZTRI AEROSPHERE is approved to treat COPD in more than 50 countries worldwide including the US, EU, China and Japan, and is currently being studied in Phase III trials for asthma.
About THARROS
THARROS is a randomized, multi-center, double-blind, parallel-group trial to investigate the effect of budesonide/glycopyrronium/formoterol fumarate (BGF) on cardiopulmonary outcomes in COPD patients. Approximately 5,000 COPD patients with cardiopulmonary risk, aged 40-80 years old, will be randomized to receive either fixed-dose triple combination therapy, BGF, or a dual bronchodilator therapy glycopyrronium/formoterol fumarate. The trial uses a novel composite endpoint combining respiratory and cardiac outcomes: the primary endpoint in the THARROS trial is time to first severe cardiac event, severe COPD exacerbation, or cardiopulmonary death.
About ATHLOS
ATHLOS is a randomized, multi-center, double-blind, three-treatment, three-period, cross-over study to investigate the effect of budesonide/glycopyrronium/formoterol fumarate vs budesonide/formoterol fumarate (an ICS/LABA) or placebo on isotime inspiratory capacity (IC) and exercise endurance time in participants with COPD who have exertional breathlessness despite treatment with monotherapy or dual COPD maintenance therapy.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide.
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