Budesonide shows positive phase 3 data against uncontrolled asthma

Budesonide (BREZTRI Aerosphere; AstraZeneca) has shown significant efficacy vs dual-combination inhaled corticosteroid toward improving symptoms in patients with uncontrolled asthma, according to results from the phase 3 KALOS and LOGOS trials.¹

The results indicated improvements of 76 mL and 90 mL in lung function from budesonide as measured by forced expiratory volume in 1 second (FEV₁) and the FEV₁ area under the curve 0 to 3 hours, respectively, vs dual therapy at 24 weeks. Significant reductions in the yearly rate of severe asthma exacerbations were also reported.

“The KALOS and LOGOS trials show that the single fixed-dose triple therapy budesonide… improved lung function, and, importantly, prevented future severe exacerbations in patients, regardless of exacerbation history,” said Alberto Papi, MD, PhD professor at the University of Ferrara.

Positive results and budesonide mechanism

KALOS and LOGOS were phase 3 randomized, double-blind, double-dummy, parallel group, multi-center trials lasting 24 to 52 weeks. These studies compared the safety and efficacy of budesonide to a fixed-dose, dual-combination therapies of budesonide, formoterol fumarate, and inhaled corticosteroids (ICS).

Positive safety results were also reported, with no new safety or tolerability signals observed in either trial. Additionally, primary endpoints were met in the qualifying trials LITHOS and VATHOS, which included approximately 1000 randomized patients.

Budesonide is a single-inhaler, fixed-dose triple-combination of formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA), a long-acting muscarinic antagonist, and glycopyrronium bromide. These components are combined with the ICS budesonide and delivered through the Aerosphere pressurized metered-dose inhaler.

Contraindications and broader impact

Contraindications of budesonide include a hypersensitivity to budesonide, glycopyrrolate, formoterol fumarate, or product excipients. Investigators noted that while LABA monotherapy has been linked to an increased risk of asthma-related death, this association has not been identified when using LABA in a fixed combination with ICS.

Experts have warned not to use budesonide more often than recommended or in combination with LABA-containing medicines to avoid increasing the risks of overdose and cardiovascular effects. Additionally, clinicians should be aware of the possibility for lower respiratory tract infections to present after ICS use.

The medication is approved to treat chronic obstructive pulmonary disease in adults across over 80 countries worldwide, including the United States, European Union, China, and Japan. This new data highlights its potential to help the 262 million patients worldwide with asthma, many of whom have an uncontrolled condition.

“With so many patients still experiencing the debilitating effects of uncontrolled asthma, we are excited about the potential for BREZTRI to improve lung function as well as prevent exacerbations in asthma,” said Sharon Barr, PhD, Executive Vice President of BioPharmaceuticals R&D, AstraZeneca.

Addressing asthma challenges in children

This treatment may also provide support to children struggling with asthma in school who face unique challenges that were discussed by Richard Wong, DO, pediatric pulmonologist at Phoenix Children’s Hospital, in an interview with Contemporary Pediatrics.² According to Wong, the start of the school year is linked to a significant increase in asthma-related emergency department visits.

More rigorous and unpredictable schedules during the school year may also lead students to struggle with adhering to maintenance therapy. Wong recommended parents have inhalers stocked to provide children the resources necessary to control asthma. Additionally, an action plan can prevent additional challenges during the school season.

“At home, families can better control exposures and reduce triggers, but school presents a much more complex environment,” said Wong. “Respiratory viruses, allergens, exercise, and environmental exposures like air pollution all contribute to increased risk.”

References

1. Positive and clinically meaningful results from the phase 3 KALOS and LOGOS trials for BREZTRI in patients with uncontrolled asthma published in The Lancet Respiratory Medicine. Business Wire. February 13, 2026. Accessed February 13, 2026. https://www.businesswire.com/news/home/20260213647522/en/Positive-and-clinically-meaningful-results-from-the-Phase-III-KALOS-and-LOGOS-trials-for-BREZTRI-in-patients-with-uncontrolled-asthma-published-in-The-Lancet-Respiratory-Medicine
2. Wong R. Richard Wong, DO, explains challenges children with asthma face in school. Contemporary Pediatrics. July 17, 2025. Accessed February 13, 2026. https://www.contemporarypediatrics.com/view/richard-wong-explains-challenges-children-asthma-school