Abstract
BACKGROUND: Adolescent patients with asthma are not thought to differ from adults in terms of clinical treatment efficacy.
AIM AND OBJECTIVE: This analysis of 6 double-blind studies (6–12 months) assessed the efficacy/safety of budesonide/formoterol (BUD/FORM) maintenance and reliever therapy (MART) in adolescent patients (12–17 yrs) with asthma.
METHODS: BUD/FORM MART was compared with active comparators (Figure) for time to first severe exacerbation (primary endpoint, except STEAM) and other efficacy parameters. Severe exacerbations were defined as hospitalisation/emergency treatment due to asthma worsening and need for oral steroids for asthma. Safety was assessed by adverse event (AE) type/incidence.
RESULTS: Overall, 1845 adolescent patients were included in the individual study efficacy population. BUD/FORM MART was similar to, or more effective than, comparators across all studies for time to first severe exacerbation, with comparable outcomes for adolescents and adults (Figure). Adult/adolescent patients using BUD/FORM MART received a lower mean daily dose of inhaled corticosteroid versus comparators, when study design allowed. AE type/incidence were similar for adults and adolescents on BUD/FORM MART versus comparators across studies.
CONCLUSIONS: The efficacy and safety of BUD/FORM MART in adolescent asthma patients is similar to that in adults.
FUNDING: AstraZeneca
- Copyright ©the authors 2016
