Albuterol-budesonide combo lowered risk of a severe asthma exacerbation: NEJM

A new study published in The New England Journal of Medicine showed that the participants with asthma who remained uncontrolled despite therapy were less likely to experience a severe asthma exacerbation when albuterol–budesonide was used as required than when albuterol was used alone.

In individuals with moderate-to-severe asthma, as-needed use of albuterol–budesonide has been demonstrated to significantly reduce the likelihood of a severe asthma exacerbation compared to as-needed use of albuterol alone. Under the trade name Airsupra®, albuterol/budesonide is an authorized inhaled corticosteroid (ICS) and short-acting beta2-agonist (SABA) asthma rescue medication.

The patients with asthma who are 18 years of age or older can use the medication to prevent or treat bronchoconstriction as needed and to lower their risk of exacerbations. There is a need for information on albuterol-budesonide in mild asthma. Thus, Craig LaForce and colleagues carried out this investigation to examine the effectiveness of using albuterol/budesonide as needed for moderate asthma.

Those aged 12 and older who had uncontrolled mild asthma despite using SABA and/or low-dose inhaled glucocorticoids or leukotriene-receptor antagonists were the subjects of a completely virtual, multicenter study. For a maximum of 52 weeks, the participants were randomized 1:1 to receive either albuterol (180 μg) + budesonide (160 μg) or albuterol alone (180 μg), administered as two inhaler actuations each dosage.

Time to first severe asthma exacerbation in the population receiving therapy was the main outcome. Systemic glucocorticoid exposure, annualized exacerbation rates, and the intention-to-treat group's delay to first exacerbation were secondary objectives.

Out of the 2516 individuals, 1797 (71.4%) finished the experiment after being randomly assigned. 74.4% of the 2421 people in the complete analytic population used a SABA alone at baseline, and 97.2% of them were 18 years of age or older. After a predetermined interim analysis, the experiment was terminated for effectiveness.

In the on-treatment efficacy population, 5.1% of participants in the albuterol–budesonide group and 9.1% of those in the albuterol group experienced a severe exacerbation, whereas in the intention-to-treat population, the corresponding rates were 5.3% and 9.4%.

Both the mean annualized total dosage of systemic glucocorticoids and the annualized rate of severe asthma exacerbations were lower with albuterol–budesonide than with albuterol. The 2 therapy groups had comparable adverse effects. Overall, when compared to albuterol alone, albuterol/budesonide dramatically decreased the likelihood of severe asthma exacerbations in people with moderate asthma.

Reference:

LaForce, C., Albers, F., Danilewicz, A., Jeynes-Ellis, A., Kraft, M., Panettieri, R. A., Jr, Rees, R., Bardsley, S., Dunsire, L., Harrison, T., Sobande, O., Surujbally, R., Trudo, F., Cappelletti, C., Papi, A., Beasley, R., Chipps, B. E., Israel, E., Pandya, H., … BATURA Investigators. (2025). As-needed albuterol-budesonide in mild asthma. The New England Journal of Medicine. https://doi.org/10.1056/NEJMoa2504544