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

Inclusion criteria

• Female or male aged ≥4 years at the time of informed consent
• Physician diagnosis of asthma with a documented history of the last 6 months
• Receiving 1 of the following inhaled asthma medications with stable dosing for at least 30 days prior to Visit 1:

• Only short/rapid-acting β2-adrenoreceptor agonist (SABA) used as needed
• Stable low-dose inhaled corticosteroid in addition to as-needed use of SABA
• Pre-bronchodilator FEV1 of ≥50 to <85% predicted normal value for adults (≥18 years of age) and ≥50% predicted normal value for subjects aged 4 to 17 years after withholding SABA ≥6 hours at Visit 1.
• Demonstrate reversibility of airflow limitation defined as a ≥15% increase in FEV1 relative to baseline after administration of Sponsor-provided SABA (Ventolin) at either Visit 1 or Visit 1a.
• Demonstrate acceptable spirometry performance acceptability/repeatability criteria
• Taken Ventolin on ≥2 days out of 7 days prior to Visit 2
• Demonstrate acceptable metered dose inhaler (MDI) administration technique as assessed by the investigator.
• Able to perform acceptable and reproducible peak expiratory flow measurements as assessed by the investigator

Exclusion criteria

• Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia)
• Systemic corticosteroids (SCS) use (any dose and any indication) within 3 months before Visit 1
• Chronic (≥3 weeks) use of SCS within 6 months prior to Visit 1
• Received any marketed (eg, omalizumab, mepolizumab, reslizumab, benralizumab) or investigational biologic within 3 months or 5 half-lives before Visit 1, whichever is longer, or any other prohibited medication
• 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)
• Life-threatening asthma defined as any history of significant asthma episode(s) requiring admission to an intensive care unit, intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within 5 years of Visit 1
• Completed treatment for lower respiratory infection within 6 weeks prior to Visit 1
• Upper respiratory infection involving antibiotic treatment not resolved within 7 days prior to Visit 1
• Hospitalizations due to asthma within 6 months prior to Visit 1
• Have taken ≥12 actuations per day of Sponsor-provided Ventolin during the run-in period prior to Visit 2 according to the below criteria:

• ≥2 days out of 14 days of run-in
• ≥3 days out of 15 to 21 days of run-in
• ≥4 days out of 22 or more days of run-in
• Unable to comply with study procedures including non-compliance with diary completion (ie, <70% subject completion of diary assessments in the last 7 days preceding Visit 2 or 4-times daily dosing, <80% compliance during the placebo run-in period).
• Historical or current evidence of a clinically significant disease
• Cancer not in complete remission for at least 5 years before Visit 1
• Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1
• History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity
• Significant abuse of alcohol or drugs, in the opinion of the investigator