AstraZeneca has published full results from the Phase III KALOS and LOGOS trials in The Lancet Respiratory Medicine, showing that BREZTRI Aerosphere, a fixed-dose triple-combination inhaler containing budesonide, glycopyrronium, and formoterol fumarate, provided statistically significant and clinically meaningful benefits for patients with uncontrolled asthma compared with standard dual-combination inhaled corticosteroid and long-acting beta2-agonist treatments, including Symbicort and PT009. In a pre-specified pooled analysis, BREZTRI improved morning pre-dose trough FEV1 by 76 mL over 24 weeks and FEV1 area under the curve by 90 mL versus dual therapy. The trials also demonstrated that BREZTRI significantly reduced the annualized rate of severe asthma exacerbations regardless of patients’ recent exacerbation history.

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Alberto Papi, Professor and Chair of Respiratory Medicine at the University of Ferrara and Director of the Respiratory Unit at S. Anna University Hospital, Ferrara, Italy, and primary investigator, stated that the results highlight the ongoing challenge faced by the 262 million people worldwide living with asthma who remain uncontrolled on dual therapy. He emphasized that BREZTRI’s combination of an ICS, LAMA, and LABA improved lung function and helped prevent severe exacerbations in patients regardless of prior history. Sharon Barr, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, said that the trial results demonstrate the potential for BREZTRI to improve lung function and reduce exacerbations in uncontrolled asthma, building on its established use in COPD. No new safety concerns were identified in the studies.

BREZTRI is approved for COPD in adults in over 80 countries including the U.S., EU, China, and Japan. Regulatory applications for asthma are under review in major regions. BREZTRI is contraindicated in patients with hypersensitivity to its components and is not a rescue therapy. Patients should use caution if taking certain medications including MAO inhibitors, CYP3A4 inhibitors, or beta-blockers, and healthcare providers should monitor for cardiovascular effects, infections, or corticosteroid-related adverse effects. Common adverse events observed in clinical trials included upper respiratory tract infections, pneumonia, back pain, oral candidiasis, influenza, muscle spasms, urinary tract infections, cough, sinusitis, diarrhea, and dysphonia. Patients with hepatic impairment should be closely monitored due to potential increased systemic exposure.

This body of evidence positions BREZTRI as a promising option for addressing unmet needs in uncontrolled asthma by combining triple therapy in a single inhaler to improve lung function and reduce exacerbation risk.

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