Quick Summary
- Objective: To evaluate Breztri Aerosphere (triple therapy) in 4,300 patients with uncontrolled asthma vs. dual-combination therapies (e.g., Symbicort).
- Reduced Exacerbations: Meaningful reduction in severe asthma attacks, regardless of prior attack history.
- Onset: Significant lung function improvement observed within 5 minutes of the first dose.
- Safety: No new safety signals; profile remains consistent with its established use in COPD.
- Regulatory Status: Applications for asthma indication are currently under review in the US, EU, China, and Japan.
AstraZeneca today announced positive results from the Phase III KALOS and LOGOS trials, demonstrating that Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) significantly improves lung function and reduces exacerbations in patients with uncontrolled asthma.
The full results, published today in The Lancet Respiratory Medicine, mark a major milestone for the triple-combination therapy, which is already a standard of care for Chronic Obstructive Pulmonary Disease (COPD).
Transformative Data for Uncontrolled Asthma
The replicate KALOS and LOGOS trials evaluated the efficacy and safety of Breztri (a single-inhaler triple therapy) against dual-combination therapies, including the widely used Symbicort.
In a pooled analysis of the two trials, Breztri achieved its primary endpoints with high statistical significance:
- Lung Function Improvement: Breztri improved lung function by 76mL (measured by morning pre-dose trough FEV1) and 90mL (measured by FEV1 AUC 0-3) over 24 weeks compared to dual therapy.
- Exacerbation Reduction: The triple therapy demonstrated clinically meaningful reductions in the annualized rate of severe asthma exacerbations, regardless of whether patients had a recent history of attacks.
Addressing an Urgent Global Need
Asthma affects an estimated 262 million people worldwide. Despite the availability of dual-action maintenance inhalers (ICS/LABA), a significant portion of patients remain “uncontrolled,” suffering from persistent breathlessness, wheezing, and life-threatening attacks.
Many patients still struggle with symptoms despite the use of dual maintenance therapy,
The KALOS and LOGOS trials show that this single fixed-dose triple therapy improved lung function and, importantly, prevented future severe exacerbations in patients.
Alberto Papi
Expanding the Breztri Portfolio
Breztri Aerosphere is currently approved in over 80 countries, including the US, EU (as Trixeo), China, and Japan for the treatment of COPD. Based on these new findings, AstraZeneca has submitted regulatory filings for the asthma indication in all major regions, which are currently under review.
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Safety and Next Steps
The safety and tolerability profile of Breztri in the KALOS and LOGOS trials remained consistent with its known profile in COPD, with no new safety signals identified.
As healthcare providers look for ways to simplify treatment regimens and improve patient adherence, the “single-inhaler” triple therapy approach is expected to become a cornerstone in the management of severe, uncontrolled asthma.
About Breztri Aerosphere
Breztri Aerosphere is a fixed-dose triple combination of budesonide (an inhaled corticosteroid), glycopyrronium (a LAMA), and formoterol fumarate (a LABA), delivered via the Aerosphere pressurized metered-dose inhaler (pMDI).
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