Test 2
What You Need to Know: Overall, the Global Initiative for Asthma guidelines and results of the current study may indicate that it is time to use an inhaled corticosteroid short-acting beta-agonist medication as initial treatment in children with mild asthma.
Article summary
For many years, as-needed treatment with short-acting beta-agonists (SABA) has been the mainstay of management of children with mild asthma. However, some guidelines now include a recommendation of inhaled corticosteroid and SABA instead of SABA alone as first-line therapy. Investigators from multiple institutions conducted a randomized trial comparing budesonide-formoterol to SABA (salbutamol) treatment in these patients. Participants were children 5–15 years old with mild asthma who were enrolled at 15 sites at New Zealand. Study patients were randomized to receive budesonide-formoterol or SABA as needed to treat asthma symptoms and followed for 52 weeks. The main study outcome was annualized rate of asthma attacks, defined as an unscheduled visit for asthma. A main secondary outcome was annualized rate of severe attacks, defined as needing systemic corticosteroids or hospital admission for asthma. These outcomes were compared in patients in the 2 treatment groups.
Data were analyzed on 360 children, 179 randomized to budesonide-formoterol and 181 to the SABA group. The annualized rate of asthma attacks per participant was 0.23 for those in the budesonide-formoterol group vs 0.41 for patients randomized to SABA (relative rate [RR], 0.55; 95% confidence interval [CI], 0.35, 0.85). The rate of asthma attacks was significantly lower with budesonide-formoterol than with SABA for those 12–15 years old, but not in children 5–11 years of age (RR, 0.72; 95% CI, 0.46, 1.12). The overall rate of severe asthma attacks was significantly lower for those in the budesonide-formoterol group than in those randomized to SABA (0.11 and 0.18, respectively; RR, 0.60; 95% CI, 0.32, 1.14).
Investigators’ conclusion: Budesonide-formoterol was superior to SABA in preventing asthma attacks in children 5–15 years old with mild asthma.
Commentary
Although Global Initiative for Asthma (GINA) guidelines recommend combination treatment with inhaled corticosteroid and SABA for children with mild asthma, the evidence supporting this recommendation in children <12 years old was lacking until the current study. The results support the recommendation, although the effect was greater in patients 12–15 years old than in those 5–11 years of age. A main strength of the current study was a 52-week follow-up period, while limitations included lack of blinding and lack of dose counters to assess inhaler use in participants in the 2 treatment groups.
James A. Taylor, MD, Scottsdale, AZ
Editor in Chief, AAP Grand Rounds
Source article: Hatter L, Holliday M, Oldfield K, et al. Budesonide-formoterol versus salbutamol as reliever therapy in children with mild asthma (CARE): a 52-week, open-label, multicentre, superiority, randomized controlled trial. Lancet. 2025;406(10511):1473-1483. Published online October 4, 2025. [Link]
