WILMINGTON, Del. - AstraZeneca (NASDAQ:AZN) has announced the commencement of the ATHLOS Phase III clinical trial to explore the effectiveness of its inhaled triple therapy BREZTRI AEROSPHERE® in reducing severe cardiopulmonary events in patients with chronic obstructive pulmonary disease (COPD).
This trial marks the first time that a therapy combining budesonide, glycopyrronium, and formoterol fumarate (BGF) is being investigated for its potential impact on health status and survival in COPD patients who are at an elevated cardiopulmonary risk, regardless of their history of exacerbations.
The ATHLOS trial has already begun dosing participants, aiming to compare the BGF triple therapy against ICS/LABA (budesonide/formoterol fumarate) or placebo. The study will assess changes in cardiopulmonary parameters, including hyperinflation and exercise endurance time, which are crucial indicators of overall health and survival prospects for individuals with COPD.
COPD, affecting approximately 391 million people worldwide, significantly increases the risk of both pulmonary and cardiac events. The disease is a leading cause of death due to its association with severe exacerbations and cardiac complications. The THARROS trial, also conducted by AstraZeneca, is another Phase III study evaluating the impact of the BGF triple therapy on COPD patients with cardiopulmonary risk factors.
Dr. Fernando Martinez, a leading investigator in the THARROS trial, highlighted the importance of such studies in advancing treatment strategies for COPD. He noted that positive results could provide critical evidence supporting the use of single inhaler, triple combination therapy to reduce severe cardiopulmonary events, potentially improving outcomes for patients with no history of exacerbations.
Sharon Barr, Executive Vice President at AstraZeneca, emphasized the company's commitment to addressing COPD as a leading cause of death and expressed hope that the THARROS study could demonstrate the potential of triple therapy in managing cardiopulmonary risk.
BREZTRI AEROSPHERE® is currently approved for the treatment of COPD in over 75 countries, including the US, EU, China, and Japan. The trial's findings could have significant implications for the future management of COPD, particularly in patients with high cardiopulmonary risk. This article is based on a press release statement from AstraZeneca.
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