The purpose of this study is to compare the effect of budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI), both administered as needed, on the annualized rate of severe asthma exacerbations in adolescents with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year.
Confirmed clinical diagnosis of asthma at least 12 months.
Receiving one of the following scheduled asthma maintenance therapies for at least 3 months with stable dosing for at least the last one month
Low-to-high-dose Inhaled corticosteroid(s) (ICS)
Low-to-high-dose ICS or ICS/long-acting β2-agonist (LABA) with or without one additional maintenance therapy from the following: leukotriene receptor antagonist (LTRA), long-acting muscarinic antagonist (LAMA), or theophylline
Life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).
Experienced > 3 severe asthma exacerbations within 12 months before screening.
Completed treatment for lower respiratory infection and severe asthma exacerbation with SCS within 4 weeks of screening.
Upper respiratory infection involving antibiotic treatment not resolved.
AstraZeneca
Lead sponsor
Parexel
Collaborator