N Engl J Med

ATS 2025: Combo inhaler cuts severe exacerbations in mild asthma

May 21, 2025

As-needed albuterol–budesonide significantly reduced severe exacerbation risk in mild asthma, offering a compelling alternative to short-acting β₂-agonist (SABA) monotherapy. These findings, presented at the American Thoracic Society (ATS) annual meeting, support a shift in practice toward anti-inflammatory reliever strategies, even in patients with mild disease.

Study details: The double-blind, decentralized phase 3b BATURA trial enrolled 2,516 patients ≥12 years of age with mild asthma uncontrolled by SABA alone or with low-dose controller therapy. Participants were randomized to receive either as-needed albuterol–budesonide (180 μg/160 μg) or albuterol alone (180 μg) for up to 52 weeks. The primary endpoint was time to first severe exacerbation.

Results: The trial was stopped early for efficacy. Severe exacerbations occurred in 5.1% of the albuterol–budesonide group vs. 9.1% in the albuterol group (hazard ratio [HR], 0.53; 95% confidence interval, 0.39–0.73; P<0.001). Annualized exacerbation rates and systemic steroid exposure were also significantly lower with the combination therapy (0.15 vs. 0.32 events/year; 23.2 mg vs. 61.9 mg/year, respectively). Adverse event rates were similar between groups.

Source:

LaForce C, et al; BATURA Investigators. (2025, May 19). N Engl J Med. As-Needed Albuterol-Budesonide in Mild Asthma. https://pubmed.ncbi.nlm.nih.gov/40388330/