Trixeo Aerosphere, marketed as Breztri Aerosphere in several countries including the United States, China and Japan, is a fixed-dose triple-combination inhaler. It combines budesonide (an ICS), formoterol fumarate (a LABA), and glycopyrronium, a long-acting muscarinic antagonist (LAMA), in a single device. The addition of a LAMA is intended to provide further symptom control beyond standard dual-therapy approaches.

Evidence from Phase III Studies

The CHMP recommendation was supported by findings from the Phase III KALOS and LOGOS clinical trials, which evaluated the efficacy and safety of the triple-combination inhaler in patients with asthma. Across the studies, Trixeo produced statistically significant improvements in lung function when compared with dual-combination ICS/LABA therapies.

A pooled analysis of data from both trials also demonstrated a meaningful reduction in the annual rate of severe asthma exacerbations relative to comparator treatments. Notably, this benefit was seen across a broad patient population, including individuals who had not experienced asthma exacerbations during the previous year.

Another key outcome was the therapy’s rapid onset of action. Trial results showed significant improvements in lung function within five minutes of the first administered dose. However, Trixeo is designed for long-term disease management and is not intended to replace rescue inhalers used during acute breathing difficulties.

Addressing Uncontrolled Asthma

Despite the availability of established therapies, asthma remains poorly controlled in a substantial proportion of patients. Experts estimate that about half of patients continue to experience inadequate disease control while receiving dual therapy, leading to persistent symptoms, impaired lung function, and a heightened risk of exacerbations.

Commenting on the CHMP opinion, Professor Alberto Papi of the University of Ferrara, Italy, highlighted the ongoing burden of uncontrolled asthma across Europe. He noted that many patients continue to face breathing difficulties, reduced lung function and recurring exacerbations that significantly affect daily life. According to Papi, access to a new triple-combination treatment option could help improve disease management and reduce the likelihood of severe flare-ups.

Trial Design and Safety Findings

The KALOS and LOGOS studies were large, replicate Phase III trials involving approximately 4,300 randomised participants. Conducted across multiple centres, the double-blind studies compared Trixeo with two dual-combination inhaled therapies containing budesonide and formoterol.

Researchers assessed lung function using measures such as trough forced expiratory volume in one second (FEV1) and FEV1 area under the curve over a three-hour period. Severe asthma exacerbation rates were also analysed using pooled data from both trials.

Importantly, investigators reported no new safety or tolerability concerns during the studies, supporting the established safety profile of the inhaler’s component medicines.

Growing Need for Additional Treatment Options

Asthma affects an estimated 363 million people globally, including nearly 43 million individuals in Europe. The chronic respiratory condition is characterised by airway inflammation and narrowing, which can lead to wheezing, coughing, chest tightness and shortness of breath. Severe exacerbations may result in hospitalisation and, in some cases, death.

With millions of new diagnoses reported worldwide each year and many patients remaining symptomatic despite standard treatment, healthcare providers continue to seek therapies that offer better disease control and fewer exacerbations.

Regulatory Status

Trixeo/Breztri has already received approval in the United States for the treatment of asthma in patients aged 12 years and older. Applications are also under review in several major markets, including Japan and China. In addition, the inhaler is widely approved for chronic obstructive pulmonary disease (COPD), with authorisations in more than 90 countries worldwide.

The positive CHMP opinion represents a significant step toward expanding the use of AstraZeneca’s triple-combination inhaler in asthma, potentially providing a new maintenance treatment option for European patients whose symptoms remain uncontrolled on standard dual therapy.