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The company has announced that the first participants have also been dosed in the ATHLOS phase 3 clinical trial, investigating budesonide/glycopyrronium/formoterol fumarate (Breztri Aerosphere).
AstraZeneca has announced it will initiate a phase 3 trial to investigate the effect of the triple-combination inhaled therapy budesonide/glycopyrronium/formoterol fumarate (BGF [Breztri Aerosphere]) on severe cardiopulmonary outcomes, including death, with individuals who have chronic obstructive pulmonary disease (COPD) and elevated cardiopulmonary risk, according to a press release from the company.1
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“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,” Fernando Martinez MD, MS, chief of the division of pulmonary and critical care medicine at Weill Cornell Medicine and New York-Presbyterian Hospital, said in the press release.1
According to the CDC, the age-adjusted prevalence of COPD has remained unchanged from 2011 to 2022, with estimates higher for women across years. Further, the age-standardized COPD death rates in adults decreased from 1999 to 2021, with a smaller difference between men and women in 2021 compared with 2019, according to the data from the CDC.2
The THARROS study will be the first prospective trial to investigate the potential of inhaled triple therapy to reduce cardiopulmonary events in COPD. The study will investigate death from respiratory and cardiac causes will be the severe cardiopulmonary outcome measures. The trial will be multi-centered and double blinded and include 5000 individuals with COPD who have cardiopulmonary risk. Patients will be aged 40 to 80 years old and will receive the triple combination therapy or dual bronchodilator therapy, glycopyrronium/formoterol fumarate, according to the press release.1
Furthermore, the company has announced that the first participants have also been dosed in the ATHLOS phase 3 clinical trial, investigating the triple therapy drug compared to inhaled corticosteroids and long-acting β-agonist, budesonide/formoterol fumarate (Symbicort; AstraZeneca), or the placebo on cardiopulmonary parameters, including hyperinflation and exercise endurance time, according to the press release. This study will include 180 individuals aged 40 to 80 years old.1
BGF is currently approved to treat COPD in 75 countries, including the United States. The drug is indicated for the maintenance treatment of individuals with COPD. The most common adverse reactions included upper respiratory tract infection, pneumonia, back pain, oral candidiasis, influenza, muscle spasms, urinary tract infection, cough, sinusitis, and diarrhea, according to the press release.1
“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,” David Berg, MD, MPH, associated physician in cardiovascular and critical care medicine at Brigham and Women’s Hospital at Harvard Medical School, said in the press release.1
