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.
“With the first-of-its-kind THARROS study, we aim to demonstrate the potential of triple therapy to address cardiopulmonary risk.”
Breztri is a fixed-dose combination of a corticosteroid (budesonide), a long-acting muscarinic antagonist (glycopyrronium) and a long-acting beta2-adrenergic agonist (formoterol fumarate), which is delivered through a pressurised metered dose inhaler.
It has been approved in multiple countries, including the US, EU and China, as a maintenance therapy for adults with COPD whose disease is not controlled well enough with a combination of inhaled medicines consisting of a long-acting beta-2 agonist plus either a corticosteroid or a long-acting muscarinic antagonist. Breztri is marketed under the brand name Trixeo Aerosphere in the EU.
The therapy generated $677m in global sales in 2023, as per AstraZeneca’s financials. According to GlobalData analysis, Breztri sales are expected to rise in the coming years, with the therapy predicted to generate $1.7bn in global sales in 2030.
GlobalData is the parent company of Clinical Trials Arena.
AstraZeneca has also dosed the first patient in the Phase III ATHLOS trial (NCT06067828) for Breztri in patients with COPD. The study evaluates the effect of Breztri compared to the dual therapy of budesonide / formoterol fumarate on exercise parameters in COPD patients. The trial is expected to enrol 180 patients and has a primary completion date of August 2025, as per ClinicalTrials.gov.
