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
Condition: Asthma
MeSH terms: Asthma
Intervention: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg; Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg; Albuterol sulfate metered-dose inhaler 180 μg
Intervention description: Budesonide/albuterol sulfate combination inhalation aerosol; Budesonide/albuterol sulfate combination inhalation aerosol; Albuterol sulfate inhalation aerosol
Intervention MeSH terms: Budesonide; Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3132.0
Sex: All
Minimum age: 4 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, multicenter, parallel-group, variable-length study to
      compare 2 doses of BDA MDI (PT027) with AS MDI (PT007) on the time to first severe asthma
      exacerbation in adult, adolescent, and pediatric subjects with moderate to severe asthma.
    

Eligibility criteria:

        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