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.
Parallel
BDA MDI
Combination productParticipants will receive oral inhalation of BDA MDI 160/180 μg taken as 2 puffs of 80/90 μg as needed.
AS MDI
Combination productParticipants will receive oral inhalation of AS MDI 180 μg taken as 2 puffs of 90 μg as needed.
Annualized rate of severe asthma exacerbations (AAER)
The effect of BDA MDI compared with AS MDI, both administered as needed, on the AAER in participants with asthma will be evaluated.
Time to first (TTF) severe asthma exacerbation
The effect of BDA MDI compared with AS MDI, both administered as needed, on the risk of a first severe asthma exacerbation in participants with asthma will be evaluated.
Annualized total systemic corticosteroids (SCS) exposure for treatment of asthma
The effect of BDA MDI compared with AS MDI, both administered as needed, on the annualized total SCS exposure for treatment of asthma in participants with asthma will be evaluated.
Number of participants with adverse events (AEs) and severe adverse events (SAEs)
The safety and tolerability of BDA MDI compared with AS MDI in participants with asthma will be assessed.
Maximum Observed Concentration (Cmax)
The PK of budesonide and albuterol in participants with asthma, following a single dose of BDA MDI will be characterized.
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AstraZeneca
Lead sponsor
Parexel
Collaborator
