AstraZeneca Launches Phase III Trial of BREZTRI for COPD

AstraZeneca has initiated a Phase III clinical trial, THARROS, to explore the effects of the inhaled triple-combination therapy BREZTRI AEROSPHERE® (budesonide/glycopyrronium/formoterol fumarate, or BGF) on individuals suffering from chronic obstructive pulmonary disease (COPD) with high cardiopulmonary risk. This study aims to evaluate severe cardiopulmonary outcomes, such as mortality, in these patients, regardless of their exacerbation history. Additionally, the first patients have received doses in the ATHLOS Phase III trial, which compares the efficacy of AstraZeneca’s triple therapy BGF to other treatments like ICS/LABA budesonide/formoterol fumarate (BFF) or a placebo in terms of cardiopulmonary measures like hyperinflation and exercise endurance, both of which are linked to patients’ health status and longevity.

Globally, COPD affects around 391 million people. The disease heightens the risk of both pulmonary and cardiac events, including severe exacerbations and heart issues, collectively known as cardiopulmonary risk. This risk intensifies after a COPD exacerbation and may remain high for up to a year following the event. A single exacerbation can double the risk of a heart attack and increase the probabilities of hospitalization and death related to cardiopulmonary issues. Cardiopulmonary complications are the leading cause of death in COPD patients.

Dr. Fernando Martinez, Chief of Pulmonary and Critical Care Medicine at Weill Cornell Medicine and New York-Presbyterian Hospital, emphasized the significance of the THARROS trial in providing critical evidence for the potential of single inhaler, triple-combination therapy in reducing severe cardiopulmonary events. Dr. David Berg from Brigham and Women’s Hospital, Harvard Medical School, highlighted the transformative impact large-scale trials have had on understanding and managing cardiovascular diseases and expressed hopes for similar advancements from THARROS in COPD management.

Sharon Barr, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, underscored the urgency of addressing COPD, which remains a leading cause of death. She noted that moderate COPD exacerbations are linked to increased risks of severe lung events and cardiovascular complications, contributing to mortality. The THARROS study seeks to demonstrate the effectiveness of triple therapy in mitigating cardiopulmonary risk.

BREZTRI AEROSPHERE® is approved for COPD treatment in 75 countries, including the US, EU, China, and Japan. The THARROS trial is a randomized, multi-center, double-blind, parallel-group study examining the impact of BGF therapy on cardiopulmonary outcomes in approximately 5,000 COPD patients aged 40-80 years. The primary endpoint is the time to the first severe cardiac event, severe COPD exacerbation, or cardiopulmonary death.

In the realm of respiratory and immunology, AstraZeneca is at the forefront with a robust portfolio aimed at meeting the unmet needs of chronic, often debilitating diseases. Their goal is to deliver life-changing medications that could potentially eliminate COPD as a principal cause of death, eradicate asthma attacks, and achieve clinical remission in immune-mediated diseases.

AstraZeneca, a science-led biopharmaceutical company based in Cambridge, UK, develops and commercializes prescription medicines in several therapeutic areas. Their innovative treatments are used globally, enhancing the lives of millions of patients.