Evaluating the Efficacy and Safety of PT027 Compared with PT007 Administered As Needed in Participants 12 to < 18 Years of Age with Asthma - ACADIA

Exclusion Criteria

• • 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.
• • Current smokers, former smokers with > 10 pack-years history, or former smokers who stopped smoking < 6 months (including all forms of tobacco, e-cigarettes [vaping], and marijuana).
• • Other significant lung disease, including regular or occasional use of oxygen.
• • Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neuropsychological, endocrine, or gastrointestinal disorders.
• • Cancer not in complete remission for at least 5 years.
• • History or hospitalization for psychiatric disorder or attempted suicide within one year.
• • Significant abuse of alcohol or drugs, in the opinion of the investigator.
• • Oral corticosteroid(s) (OCS)/SCS use (any dose and any indication) within 4 weeks before Visit 1 or chronic use of OCS/SCS (≥ 3 weeks use in 3 months prior to Visit 1).
• • Use of any oral SABAs within one month.
• • Having a known or suspected hypersensitivity to albuterol/salbutamol, or budesonide and/or their excipients.