Early intervention of recent onset mild persistent asthma in children aged under 11 yrs: the Steroid Treatment As Regular Therapy in early asthma (START) trial

Inhaled corticosteroids are known to be effective in persistent asthma, but their long‐term effect in mild persistent disease of recent onset, which is particularly relevant in children, requires clarification. The objective of this study was to determine the long‐term efficacy of regular inhaled low‐dose budesonide in children aged <11 yrs with mild persistent asthma with onset within 2 yrs of enrollment. Children aged 5–10 yrs formed part of the population of the inhaled Steroid Treatment As Regular Therapy in early asthma (START) study, and they were randomized in a double‐blind manner to treatment with once daily budesonide 200 μg or placebo via TurbuhalerTM in addition to usual clinical care and other asthma medication. The double‐blind treatment phase continued for 3 yrs. Of the 1974 children, 1000 in the budesonide group and 974 in the placebo group, were analyzed for efficacy. Addition of once‐daily budesonide to usual care was associated with a significant increase in the time to first severe asthma‐related event (SARE) and significantly reduced risk of SARE over 3 yrs. The hazard ratio relative to usual care (placebo) was 0.60 (95% confidence interval: 0.40–0.90; p = 0.012), with a relative risk reduction of 40%. Children receiving budesonide also needed significantly less intervention with other inhaled corticosteroids (12.3% vs. 22.5% over 3 yrs; p < 0.01), with trends towards decreased usage of oral/systemic corticosteroids and inhaled short‐acting β2‐agonists. Budesonide treatment also had a significant beneficial effect on lung function relative to placebo. In conclusion, early intervention adding once‐daily budesonide to usual care in children with mild, persistent asthma of recent onset reduces the long‐term risk and frequency of SAREs and improves lung function compared with usual care alone.