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Severe Exacerbations Down With As-Needed Albuterol-Budesonide for Mild Asthma

Medically reviewed by Carmen Pope, BPharm. Last updated on May 23, 2025.

By Elana Gotkine HealthDay Reporter

FRIDAY, May 23, 2025 -- As-needed albuterol-budesonide yields a lower risk for severe asthma exacerbation among patients with mild asthma, according to a study published online May 19 in the New England Journal of Medicine to coincide with the American Thoracic Society 2025 International Conference, held from May 18 to 21 in San Francisco.

Craig LaForce, M.D., from North Carolina Clinical Research in Raleigh, and colleagues conducted a phase 3b multicenter trial involving persons aged 12 years or older with uncontrolled mild asthma despite treatment with a short-acting β₂-agonist with or without a low-dose inhaled glucocorticoid or leukotriene-receptor antagonist. Participants were randomly assigned to receive either a fixed-dose combination of 180 μg of albuterol and 160 μg of budesonide or 180 μg of albuterol alone on an as-needed basis for up to 52 weeks.

The full analysis population included 2,421 participants: 1,209 assigned to albuterol-budesonide and 1,212 to albuterol. At a prespecified interim analysis, the trial was stopped for efficacy. The researchers found that a severe exacerbation occurred in 5.1 and 9.1 percent, respectively, of those in the albuterol-budesonide and the albuterol groups in the on-treatment efficacy population (hazard ratio, 0.53) and 5.3 and 9.4 percent, respectively, in the intention-to-treat population (hazard ratio, 0.54). A lower annualized rate of severe asthma exacerbations was seen with albuterol-budesonide versus albuterol (0.15 versus 0.32; rate ratio, 0.47); the mean annualized total dose of systemic glucocorticoids was also lower with albuterol-budesonide (23.2 versus 61.9 mg per year).

"The BATURA trial showed that as-needed albuterol-budesonide was efficacious in reducing the risk of severe asthma exacerbations among participants 12 years of age or older with uncontrolled disease despite treatment for mild asthma," the authors write.

Several authors disclosed ties to biopharmaceutical companies, including AstraZeneca and Bond Avillion 2 Development, both of which funded the study.

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Posted May 2025

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