Abstract
Background: The efficacy of budesonide+formoterol therapy compared with high-dose salmeterol+fluticasone therapy plus short-acting β-agonist (SABA) has not beenevaluated specifically in children. Objectives: To evaluate the efficacy and safety of budesonide+formoterolcombination therapy two times a day plus as needed compared with salmeterol+fluticasone two times a dayplusSABA (as needed) in children in China. Methods: This prospective cohort study included 164 children with persistent asthma (aged 12-17years) who had experienced a minimum of one asthma exacerbation in12months prior to the study. The primary outcome was the time to the first severe exacerbation. Results: Eighty-twochildren were assigned to each of twogroups. The exacerbation rate per 100 patients per year was notfound to besignificantly different. The number of patients with hospitalization/emergency room therapy was lower inbudesonide+formoterol group, but the risk difference was not statistically significant. Asthma control measures showed comparable effects. Bothtreatments 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.
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