The European Commission has approved Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate dihydrate) as a maintenance treatment for asthma in patients aged 12 years and older who remain inadequately controlled on a combination of a medium-dose inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA). The decision extends the EU label for AstraZeneca's fixed-dose triple inhaler, which has been approved for chronic obstructive pulmonary disease in more than 90 countries since 2020. AstraZeneca said the approval makes Trixeo the first triple-combination therapy in a single inhaler authorized in the EU for this patient population, independent of prior exacerbation history.
The approval covers the 320/28.8/10 μg dose delivered via the Aerosphere pressurised metered-dose inhaler (pMDI). Trixeo is indicated as maintenance therapy only and is not intended to relieve acute bronchospasm or replace a rescue inhaler. The same formulation is marketed as Breztri Aerosphere in the US, Japan, and China; AstraZeneca said Breztri received US approval for asthma in April 2026, and a regulatory filing for the asthma indication in China is currently under review.
The EC decision was based on results from the replicate Phase III KALOS (NCT04609878) and LOGOS (NCT04609904) trials, which together enrolled approximately 4,300 randomised adult and adolescent patients with inadequately controlled asthma. In the individual trials, the primary endpoint was change from baseline in morning pre-dose trough forced expiratory volume in one second (FEV₁) over 24 weeks versus dual ICS/LABA therapy. In the pooled analysis — the prioritised endpoint in the EMA submission — Trixeo demonstrated a statistically significant reduction in the annualised rate of severe asthma exacerbations compared with combined ICS/LABA comparators across a broad population, including patients with no exacerbations in the prior year. Results were published in The Lancet Respiratory Medicine in February 2026. No new safety or tolerability signals were identified.
Trixeo combines three complementary mechanisms in a single inhaler: budesonide suppresses airway inflammation via glucocorticoid receptor activation; glycopyrronium bromide blocks M3 muscarinic receptors to reduce bronchoconstriction; and formoterol fumarate activates β2-adrenergic receptors to produce sustained bronchodilation. The Aerosphere co-suspension delivery platform, acquired by AstraZeneca through its USD 1.15 billion purchase of Pearl Therapeutics in 2013, enables consistent co-delivery of all three components from a pMDI.