Similar safety profile seen in children with mild asthma aged 5 to 15 years
By Lori Solomon HealthDay Reporter
WEDNESDAY, Oct. 8, 2025 (HealthDay News) — In children aged 5 to 15 years with mild asthma, budesonide-formoterol reliever monotherapy is superior to salbutamol for preventing asthma attacks, according to a study published in the Oct. 4 issue of The Lancet.
Lee Hatter, M.D., from the Medical Research Institute of New Zealand in Wellington, and colleagues compared the efficacy of combination inhaled corticosteroid-formoterol reliever monotherapy versus short-acting β2-agonist (SABA) reliever monotherapy on the rate of asthma attacks in children. The analysis included 360 children (aged 5 to 15 years) with mild asthma who were randomly assigned in a 1:1 fashion to either budesonide 50 µg-formoterol 3 µg, two actuations as needed (179 participants), or salbutamol 100 µg, two actuations as needed (181 participants).
The researchers found that the annualized rate of asthma attacks was lower in the budesonide-formoterol group than in the salbutamol group (cluster-adjusted rates, 0.23 versus 0.41 per participant per year [relative rate, 0.55; 95 percent confidence interval (CI), 0.35 to 0.86; P = 0.012]). The number of participants with at least one adverse event was similar between the groups (91 percent in the budesonide-formoterol group and 92 percent in the salbutamol group; odds ratio, 0.79; 95 percent CI, 0.35 to 1.79).
“This is a key step in addressing the evidence gap that exists between asthma management in adults and children,” Hatter in a statement. “For the first time, we have demonstrated that the budesonide-formoterol 2-in-1 inhaler, used as needed for symptom relief, can significantly reduce asthma attacks in children with mild asthma. This evidence-based treatment could lead to improved asthma outcomes for children worldwide.”
One author disclosed ties to the pharmaceutical industry.
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