AZ launches triple-combination COPD inhaler Breztri in KOR

Clinical trial data show 24% relative reduction in COPD exacerbation risk vs LAMA/LABA

Breztri Aerosphere

AstraZeneca Korea (Country President: Eldana Sauran) announced the launch of ‘Breztri Aerosphere (budesonide, glycopyrronium, formoterol),’ as a maintenance therapy for moderate-to-severe chronic obstructive pulmonary disease (COPD).

Breztri Aerosphere is a single-inhaler triple-combination therapy that combines an inhaled corticosteroid (ICS), a long-acting beta-2 agonist (LABA), and a long-acting muscarinic antagonist (LAMA) in a single inhaler. It is indicated as a maintenance treatment for adult COPD patients to control symptoms and reduce exacerbations, and is administered twice daily.

The clinical efficacy and safety profile of Breztri Aerosphere have been established through global Phase III trials, including ETHOS and KRONOS.

The ETHOS (The Efficacy and Safety of Triple Therapy in Obstructive Lung Disease) study was a 52-week, multicenter, randomized, double-blind Phase III trial involving 8,588 patients aged 40–80 with moderate-to-very severe COPD.

Results showed that Breztri Aerosphere reduced the annual rate of moderate or severe COPD exacerbations by approximately 24% compared with LAMA/LABA dual therapy, and by about 13% compared with ICS/LABA, demonstrating statistically significant results.

A post-hoc analysis of ETHOS also demonstrated a significant reduction in all-cause mortality in the Breztri treatment group compared with LAMA/LABA.

In another pivotal trial, KRONOS, Breztri Aerosphere demonstrated improvements in lung function.

The 24-week global Phase III study enrolled 1,902 patients with moderate-to-very severe COPD. At Week 24, Breztri improved lung function by 22 mL compared with LAMA/LABA and by 74 mL compared with ICS/LABA (BFF MDI).

COPD is a representative chronic respiratory disease caused by abnormalities in the airways and alveoli, such as bronchitis, bronchiolitis, and emphysema. It is characterized by chronic respiratory symptoms such as shortness of breath and coughing, and is a heterogeneous disease involving persistent and progressive airway obstruction. Compared to the general population, patients with COPD tend to develop various comorbidities at an earlier age. Factors such as smoking, aging, and chronic conditions associated with the disease itself, which include cardiovascular disease, musculoskeletal disorders, and diabetes, further increase disease burden.

The 2026 Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines recommend triple therapy with ICS, LAMA, and LABA in patients receiving ICS+LABA who are currently not experiencing an exacerbation but have a high symptom burden, or who are experiencing an exacerbation and have a blood eosinophil count of 100 cells/μL or higher.

The guidelines also note that using a single inhaler can improve treatment convenience and adherence compared with multiple inhalers.

Ji-young Kim, Executive Vice President of the Respiratory Business Unit at AstraZeneca Korea, stated, “Breztri Aerosphere is a treatment option that has demonstrated reductions in exacerbations and improvements in lung function in global clinical trials, offering a new treatment option for COPD patients in Korea. AstraZeneca Korea will continue to strive to improve the treatment environment and disease management for patients with respiratory diseases.”

Breztri Aerosphere is a pMDI (pressurized metered-dose inhaler) designed to uniformly disperse drug particles using Aerosphere delivery technology, ensuring that the medication is delivered throughout both the large and small airways.

pMDIs can be used by patients with insufficient inhalation flow rates and offer the advantage of delivering a consistent dose with each actuation. Additionally, as a single inhaler capable of administering three medications simultaneously, it can help improve treatment convenience and medication adherence for patients.