CLINICAL QUESTION: Is as-needed albuterol-budesonide superior to albuterol alone in patients with mild asthma?
BACKGROUND: Although patients with mild asthma are often considered low risk, they still can have severe exacerbations. Typically, these patients rely on short-acting beta-2 agonists (SABAs) for as-needed symptoms, but SABAs do not address airway inflammation. Data for patients with moderate to severe asthma support the use of combined SABA-inhaled corticosteroid rescue therapy.
STUDY DESIGN: Randomized, double-blinded
SETTING: Multiple U.S. centers
SYNOPSIS: More than 2,400 patients aged 12 or older (97% were over age 18) were enrolled and randomized to either use albuterol alone or albuterol-budesonide as needed for asthma symptoms. The trial was stopped early for efficacy after an interim analysis showed a 47% lower risk of severe exacerbations with albuterol-budesonide (P <0.001). Rates of severe exacerbations and systemic corticosteroid exposure were also significantly lower in the albuterol-budesonide group. Adverse events were similar between the two groups.
BOTTOM LINE: Incorporating an inhaled corticosteroid into rescue therapy can significantly improve outcomes in patients with mild asthma when compared to SABA alone.
CITATION: LaForce C, et al. As-needed albuterol-budesonide in mild asthma. N Engl J Med. 2025;393(2):113-124. doi: 10.1056/NEJMoa2504544.
Dr. Zabih
Dr. Zabih is a hospitalist at the Nebraska Medical Center and an assistant professor in the department of internal medicine at the University of Nebraska Medical Center, both in Omaha, Neb.