Budesonide/formoterol maintenance and reliever therapy in adolescent patients with asthma

Asthma control is often suboptimal in adolescents, but few studies have evaluated asthma treatments in this population. This post hoc analysis assessed the efficacy and safety of budesonide/formoterol (BUD/FORM) maintenance and reliever therapy (MART) for treatment of persistent asthma in adolescent (age 12-17 years) subgroups within six randomised, double-blind trials. The primary end-point was time to first severe exacerbation. Secondary end-points included number of severe exacerbations, asthma-related symptoms, night-time awakenings, morning peak expiratory flow, forced expiratory volume in 1 s, as-needed medication use and five-item asthma control questionnaire scores. In adolescents (n=1847), BUD/FORM MART was similar to or more effective than comparators across each of the studies in reducing the risk of a first severe exacerbation (hazard ratios (HR) BUD/FORM MART versus comparators 0.15-1.01; pooled HR 0.49, 95% CI 0.34-0.70), with comparable outcomes to the adult subgroups (n=12 197). Similar treatment benefits for BUD/FORM MART were observed for secondary end-points. As-needed medication use was lower with BUD/FORM MART than comparators, and BUD/FORM as-needed use was lower in adolescents than adults. Treatment was well tolerated. This analysis supports the use of BUD/FORM MART in adolescents with persistent asthma, its efficacy and safety being consistent with that reported for adults.