AstraZeneca’s Trixeo has been approved in the EU as a maintenance treatment for asthma in patients aged 12 and older who remain uncontrolled on dual inhaled therapy.

EU approval expands Trixeo use

The European Commission approval covers patients whose asthma is not adequately controlled with a combination of a medium-dose inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA).

Trixeo is a fixed-dose triple-combination inhaler containing budesonide, glycopyrronium and formoterol fumarate dihydrate. It combines an ICS and LABA with a long-acting muscarinic antagonist (LAMA) in a single inhaler.

The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and is based on results from the KALOS and LOGOS Phase 3 trials.

Across the trials, Trixeo produced statistically significant improvements in lung function compared with the combined ICS/LABA comparator groups. A pooled analysis also showed a statistically significant reduction in the annualised rate of severe asthma exacerbations.

The analysis included patients with and without asthma exacerbations in the previous year.

Alberto Papi, professor and chair of respiratory medicine at the University of Ferrara and primary investigator, said: “Every day, I see patients whose asthma remains uncontrolled despite maintenance treatment, leaving them with persistent symptoms like difficulty breathing and declining lung function and at risk of exacerbations, which can have serious health consequences.”

Papi added that the EU approval provides a single-inhaler triple-combination treatment option for patients aged 12 and older with uncontrolled asthma.

Phase 3 trials support approval

KALOS and LOGOS were randomised, double-blind, double-dummy, parallel-group, multi-centre Phase 3 trials evaluating the efficacy and safety of Trixeo compared with dual combinations of budesonide and formoterol.

Approximately 4,300 patients were randomised across the two studies.

The individual trials assessed changes in lung function, including morning pre-dose trough FEV1 over 24 weeks. A key secondary endpoint assessed lung function over the three hours following dosing.

The pooled analysis used data from both trials to assess the rate of severe asthma exacerbations compared with combined ICS/LABA treatment.

Trixeo also showed a statistically significant improvement in lung function within five minutes of the first dose in a key secondary endpoint.

The treatment is intended as maintenance therapy and is not designed to relieve sudden breathing problems or replace a rescue inhaler.

Results from KALOS and LOGOS were published in The Lancet Respiratory Medicine in February 2026.

No new safety or tolerability signals were identified in the trials.

Triple-combination treatment for asthma

Asthma affects hundreds of millions of people worldwide and remains uncontrolled in many patients despite standard maintenance treatment.

Symptoms can include wheezing, breathlessness, chest tightness and coughing, while uncontrolled disease can lead to exacerbations and impaired lung function.

Ruud Dobber, executive vice president and president of AstraZeneca’s BioPharmaceuticals business unit, said: “Today’s approval in asthma builds on Trixeo’s established role in improving outcomes in patients with COPD.”

Trixeo is marketed as Breztri Aerosphere in the US, China and Japan. The treatment is also approved for asthma in the US and Japan, while regulatory applications are under review in other regions.

The EU approval adds asthma to Trixeo’s established use in COPD and extends the availability of a single-inhaler triple-combination approach to patients aged 12 and older whose asthma remains uncontrolled on dual inhaled therapy.