A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) in Adults and Children 4 Years of Age or Older With Asthma

Inclusion Criteria:

1. Female or male aged ≥4 years at the time of informed consent

2. Physician diagnosis of asthma documented for at least 1 year

3. Receiving 1 of the following scheduled asthma maintenance therapies for 3 months with
stable dosing for at least the last 4 weeks before Visit 1:

- Medium-to-high-dose inhaled corticosteroid (ICS)

- Medium-to-high-dose ICS and 1 additional maintenance therapy from the following:
leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists
(LAMA), or theophylline

- Low-to-high-dose ICS in combination with long-acting β2-adrenoreceptor agonist
(LABA) with or without one additional maintenance therapy from the following:
LTRA, LAMA, or theophylline

4. Prebronchodilator forced expiratory volume in 1 second (FEV1) of ≥40 to <90% predicted
normal value for adults and adolescents, and ≥60 to <100% predicted normal value for
subjects aged 4 to 11 years after withholding specified medications including
short/rapid-acting β2-adrenoreceptor agonist (SABA)

5. Demonstrate reversibility at Visit 1, with an increase in FEV1 ≥12% (and ≥200 mL for
subjects aged ≥18 years) relative to baseline after administration of sponsor provided
Ventolin via central spirometry. One re-test for reversibility testing is allowed
within the screening period in advance of Visit 2

6. Demonstrate acceptable spirometry performance (i.e., meet American Thoracic
Society/European Respiratory Society acceptability/repeatability criteria)

7. A documented history of at least 1 severe asthma exacerbation within 12 months before
Visit 1

8. Able to perform acceptable and reproducible peak expiratory flow (PEF) measurements as
assessed by the investigator

Exclusion Criteria:

1. Chronic obstructive pulmonary disease or other significant lung disease (e.g., chronic
bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or
bronchopulmonary dysplasia)

2. Oral corticosteroid/SCS use (any dose and any indication) within 6 weeks before Visit
1

3. Chronic use of oral corticosteroids (OCS, ≥3 weeks use in 3 months prior to Visit 1)

4. Having received any marketed (e.g., omalizumab, mepolizumab, reslizumab, benralizumab)
or investigational biologic within 3 months or any other prohibited medication

5. Current smokers, former smokers with >10 pack-years history, or former smokers who
stopped smoking <6 months before Visit 1 (including all forms of tobacco, e-cigarettes
[vaping], and marijuana)

6. 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) within 5 years of Visit 1

7. Historical or current evidence of a clinically significant disease

8. Cancer not in complete remission for at least 5 years

9. Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1

10. History of psychiatric disease, intellectual deficiency, poor motivation, or other
conditions if their magnitude is limiting informed consent validity

11. Significant abuse of alcohol or drugs