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Efficacy and safety of as-needed albuterol-budesonide versus albuterol in patients with asthma aged 12 to <18 years: design of the randomised, double-blind, parallel-group phase IIIb ACADIA trial - Pu

4 days ago
  • #adolescent-health
  • #clinical-trial
  • #asthma
  • The ACADIA trial evaluates as-needed albuterol-budesonide vs. albuterol in adolescents (12-<18 years) with asthma.
  • Primary endpoint: annualized rate of severe asthma exacerbations.
  • Secondary endpoints include time to first severe exacerbation and systemic corticosteroid exposure.
  • Trial design: randomized, double-blind, parallel-group, phase IIIb, involving 440 participants.
  • Ethical approval obtained; results to be presented at congresses and published in journals.
  • Bayesian dynamic borrowing used to minimize adolescent exposure to study medications.