Budesonide/formoterol versus salmeterol/fluticasone for asthma in children: an effectiveness and safety analysis

Background: The efficacy of budesonide + formoterol therapy compared with high-dose salmeterol + fluticasone therapy plus short-acting β-agonist (SABA) has not been evaluated specifically in children. Objectives: To evaluate the efficacy and safety of budesonide + formoterol combination therapy two times a day plus as needed compared with salmeterol + fluticasone two times a day plus SABA (as needed) in children in China. Methods: This prospective cohort study included 164 children with persistent asthma (aged 12–17 years) who had experienced a minimum of one asthma exacerbation in 12 months prior to the study. The primary outcome was the time to the first severe exacerbation. Results: Eighty-two children were assigned to each of two groups. The exacerbation rate per 100 patients per year was not found to be significantly different. The number of patients with hospitalization/emergency room therapy was lower in budesonide + formoterol group, but the risk difference was not statistically significant. Asthma control measures showed comparable effects. Both treatments were well-tolerated. Conclusion: No significant differences were observed in the outcome measures between the groups. Budesonide + formoterol therapy is a favorable approach in terms of a low load of ICS, steroid exposure, need for multiple inhalers and cost.