A major new study has provided evidence that treatment for childhood asthma could be significantly improved by replacing traditional salbutamol relievers with budesonide–formoterol. This randomised controlled trial focused on children aged 5–15 years and found that budesonide–formoterol reduced asthma attacks by 45% compared with salbutamol. Importantly, this benefit was achieved without affecting growth or lung function, and the safety profile was similar between the two groups.
These findings build on results from earlier adolescent and adult studies, including SYGMA 1 and Novel START, where budesonide–formoterol was shown to cut asthma attacks by more than half compared with short-acting β2-agonist (SABA) therapy alone. The new trial now extends that evidence to younger patients with mild disease.
Age and Gender Patterns in Childhood Asthma
The trial highlighted some important differences in how children respond to treatment. Older children (12–15 years) appeared to gain greater protection from budesonide–formoterol than younger ones. One explanation is that adolescents can use inhalers independently, while younger children often rely on parents or carers to recognise worsening asthma symptoms, potentially delaying treatment.
Another interesting observation was that boys might respond better than girls. Since childhood asthma outcomes are often worse in boys before puberty, this finding deserves further exploration, though subgroup results should be interpreted cautiously due to smaller numbers.
Rethinking Treatment for Mild Childhood Asthma
Asthma is one of the most common chronic conditions in children, causing significant morbidity and, in rare cases, death even when considered mild. This study shows that an ICS–formoterol reliever strategy can offer stronger protection against attacks than SABA-only treatment, without additional risks.
Reassuringly, there was no evidence of impaired growth, a concern often raised with inhaled corticosteroids. The results are also consistent with international asthma guidelines, which recommend ICS–formoterol over salbutamol alone in older populations.
Overall, the trial provides compelling evidence that childhood asthma treatment could be safer and more effective if budesonide–formoterol is adopted as the preferred reliever therapy from as early as age five.
Reference
Hatter L et al. Budesonide–formoterol versus salbutamol as reliever therapy in children with mild asthma (CARE): a 52-week, open-label, multicentre, superiority, randomised controlled trial. Lancet. 2025;DOI:10.1016/S0140-6736(25)00861-X.
