The Phase III THARROS trial will evaluate the effect of triple-combination inhaled therapy Breztri ((budesonide / glycopyrronium / formoterol fumarate) on the reduction of cardiopulmonary events in COPD patients
AstraZeneca has launched a Phase III THARROS trial to evaluate the efficacy of its triple-combination inhaled therapy Breztri (budesonide / glycopyrronium / formoterol fumarate or BGF) in reducing severe cardiopulmonary outcomes in patients with chronic obstructive pulmonary disease (COPD)
The company plans to use a novel composite endpoint of the time to first severe cardiac event, severe COPD exacerbation, or cardiopulmonary death. This composite endpoint which combines both respiratory and cardiac outcomes will also serve as the study’s primary endpoint.
The randomised, double-blind Phase III THARROS trial (NCT06283966) expects to enrol 5,000 patients aged 40-80 years who have COPD with cardiopulmonary risk. The participants will either receive Breztri or a dual bronchodilator therapy of glycopyrronium / formoterol fumarate.
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,” said Sharon Barr, executive vice-president, BioPharmaceuticals R&D, AstraZeneca.
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