AstraZeneca today announced the initiation of the Phase 3 ATHLOS and THARROS trials evaluating the effects of Breztri Aerosphere budesonide / glycopyrronium / formoterol fumarate MDI on cardiopulmonary parameters and outcomes (including death) in COPD patients. Breztri was approved by the FDA for the treatment of COPD in July 2020. In August 2023, the agency issued a warning letter to AstraZeneca citing false or misleading claims about Breztri’s efficacy, including claims related to a reduction in all-cause mortality.
According to AstraZeneca, the ATHLOS trial will compare the triple therapy to budesonide / formoterol fumarate and placebo in 180 COPD patients, measuring effects on isotime inspiratory capacity and exercise endurance capacity. The company says that dosing has begun in that study.
The 3-year THARROS trial is expected to enroll 5,000 COPD patients with elevated cardiopulmonary risk who will receive either the triple combination or glycopyrronium / formoterol fumarate. The primary endpoint for the THARROS trial is time to first severe cardiac event or exacerbation, with “Serious Adverse Events (SAEs) and Adverse Events leading to discontinuation (DAEs), Adverse Events of Special Interest (AESIs) of pneumonia leading to hospitalization or death” as an additional endpoint.
AstraZeneca Executive VP, BioPharmaceuticals R&D, Sharon Barr commented, “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.”
Read the AstraZeneca press release.
