AstraZeneca announced that its triple combination inhaled therapy Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) will be evaluated in a new phase 3 trial in patients with chronic obstructive pulmonary disease (COPD) and elevated cardiopulmonary risk.
Breztri Aerosphere is a single inhaler, fixed-dose triple combination therapy of budesonide, an inhaled corticosteroid with glycopyrrolate, a long-acting muscarinic antagonist, and formoterol fumarate, a long-acting beta2-agonist. It is currently approved by the Food and Drug Administration for the maintenance treatment of COPD.
In patients with COPD, the risk of both pulmonary and cardiac events is elevated, especially after a COPD exacerbation. The main outcome of the phase 3 THARROS trial (ClinicalTrials.gov Identifier: NCT06283966) will be to assess the efficacy of Breztri Aerosphere on reducing severe cardiopulmonary events (ie, death from respiratory and cardiac causes) in COPD patients who are at increased cardiopulmonary risk.
To be eligible for inclusion, study participants have to fulfill at least 1 of the following cardiovascular (CV) disease/risk factor criteria. These include established cardiovascular disease (CVD), a combination of CV risk factors (eg, hypertension, diabetes, chronic kidney disease, dyslipidemia, obesity), a high risk of CVD (determined using an established CV risk assessment tool), or CT coronary artery calcification.
“The 2024 GOLD Report highlights the treatment effect of nonpharmacologic interventions and inhaled triple combination therapies on mortality,” said 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 Coordinating Investigator in the THARROS trial. “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.”
The Company also reported that the first COPD patients have been dosed in the phase 3 ATHLOS trial (ClinicalTrials.gov Identifier: NCT06067828), which is evaluating Breztri Aerosphere vs budesonide/formoterol fumarate or placebo on cardiopulmonary parameters including hyperinflation and exercise endurance time.
This article originally appeared on MPR
