FDA approves triple inhaled therapy for COPD
The FDA has approved triple inhaled therapy for maintenance treatment of patients with COPD, according to a press release from AstraZeneca.
Breztri Aerosphere is a single-inhaler, fixed-dose, triple combination of budesonide, an inhaled corticosteroid, with glycopyrrolate, a long-acting muscarinic antagonist, and formoterol fumarate, a long-acting beta2-agonist, delivered in a pressurized metered-dose inhaler.
FDA approval was based on results from the phase 3 ETHOS trial, which showed a significant reduction in moderate or severe COPD exacerbations compared with dual-combination therapy, according to the release.
Healio previously reported results of ETHOS, a phase 3, randomized, double-blind, multicenter, parallel-group trial that examined the safety and efficacy of triple therapy. Patients were randomly assigned to receive twice-daily inhaled triple combination therapy (320 µg or 160 µg budesonide, 18 µg glycopyrrolate and 9.6 µg formoterol) or one of two dual-combination therapies ( 18 µg glycopyrrolate plus 9.6 µg formoterol or 320 µg budesonide plus 9.6 formoterol). Results showed that the triple-therapy group had a 24% lower rate of COPD exacerbations compared with glycopyrronium/formoterol fumarate (P < .001) and a 13% reduction compared with PT009 (budesonide/formoterol fumarate) (P = .003).
In the KRONOS study, researchers evaluated lung function changes in low-risk patients with COPD treated with Breztri Aerosphere and three other combination therapies. Results showed that treatment with Breztri Aerosphere significantly improved lung function and reduced overall COPD exacerbations.
“Preventing exacerbations is central to the management of chronic obstructive pulmonary disease. Even a single exacerbation can have a negative impact on a patient’s lung function and quality of life, and it can increase the risk of death,” Fernando J. Martinez, MD, FCCP, chief of the division of pulmonary and critical care medicine at Weill Cornell Medicine and New York-Presbyterian Weill Cornell Medical Center, said in the release. “Breztri Aerosphere has demonstrated significant benefits in reducing exacerbations in patients suffering from COPD.”
Breztri Aerosphere is approved in Japan and China and is under regulatory review in the European Union for the treatment of patients with COPD.
Editor's note: This article was updated on July 27, 2020, with updated results for dual therapies.