Efficacy and safety of as-needed budesonide-formoterol in adolescents with mild asthma

Abstract Background Medication adherence is challenging for adolescents. In mild asthma, as-needed budesonide-formoterol (BUD-FORM) reduces severe exacerbations compared with as-needed short-acting beta2-agonists (SABA), similar to the reduction with maintenance budesonide. Objective This post hoc pooled analysis of SYGMA 1 and 2 assessed the efficacy and safety of as-needed BUD-FORM in adolescents. Methods SYGMA 1 and 2 were 52-week, double-blind studies (NCT022149199; NCT02224157) in patients ≥12 years with mild asthma. Patients were randomized to twice-daily placebo + as-needed BUD-FORM 200/6μg, twice-daily BUD 200μg + as-needed terbutaline (BUD maintenance), or twice-daily placebo + as-needed terbutaline 0.5mg (SYGMA 1 only). Annualized severe exacerbation rates, maintenance treatment adherence and safety (including change in height) were compared between treatment groups in adolescents (aged ≥12− Results Severe exacerbation rate was similar with as-needed BUD-FORM and BUD maintenance (pooled analysis: 0.08 vs 0.07/year, p=0.634), and was significantly lower with as-needed BUD-FORM versus as-needed terbutaline (SYGMA 1: 0.04 vs 0.17/year, p=0.005). Median adherence was 73% in SYGMA 1 and 51% in SYGMA 2. Change in height from baseline in adolescents aged ≥12– Conclusions In adolescents with mild asthma, as-needed BUD-FORM was superior to as-needed terbutaline for severe exacerbation reduction, with similar efficacy to BUD maintenance. As-needed BUD-FORM provides an alternative treatment option for adolescents with mild asthma, without needing daily treatment.