AstraZeneca has reported positive findings from the Phase III ETHOS trial that evaluated Breztri Aerosphere for the treatment of patients with severe chronic obstructive pulmonary disease (COPD).
The drug was formerly known as PT010.
Breztri Aerosphere is a combination of budesonide, glycopyrronium and formoterol fumarate.
At both standard and low budesonide doses, Breztri Aerosphere showed a significant reduction in the rate of moderate or severe exacerbations compared to dual-combination therapies Bevespi Aerosphere and PT009.
Dual-combination therapies Bevespi Aerosphere and PT009, which are used as comparators in the trial, represent recommended therapeutic classes for the COPD treatment.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “Exacerbations are devastating events for patients and can lead to a permanent loss of lung function.
“The Phase III ETHOS trial builds on the Phase III KRONOS data, which together show Breztri Aerosphere’s ability to reduce exacerbation risk in a broad range of patients with COPD, irrespective of whether they have had an exacerbation in the previous 12 months.”
AstraZeneca said that the safety and efficacy of Breztri Aerosphere were consistent with the known profiles of the dual comparators.
According to the company, all combination therapies were administered in a pressurised metered-dose inhaler (pMDI), which uses the innovative Aerosphere delivery technology.
ETHOS trial lead investigator Klaus Rabe said: “The Phase III ETHOS trial results are exciting and demonstrate that Breztri Aerosphere significantly reduces the rate of exacerbations.
“This is also the first time we have seen the benefit of fixed-dose triple-combination therapy at two inhaled corticosteroid doses, which could transform treatment practice by allowing physicians to select the optimal dose for individual patients.”