Assessment of the Safety, Efficacy, PK, and Extrapulmonary Pharmacodynamics (PD) of Albuterol Sulfate Pressurized Inhalation Suspension (Hereafter Referred to as AS MDI) Compared to Proventil as an Active Control in Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: AS MDI; Proventil
Intervention description: AS MDI 1+1+2+4+8 inhalations of 90 μg per inhalation; Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation
Intervention MeSH terms: Albuterol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      This is a randomized, cumulative dose, open-label, 2-period crossover, multi-center study to
      assess the safety, efficacy, PK, and extrapulmonary PD of cumulative doses of AS MDI compared
      to cumulative doses of Proventil as an active control in subjects with mild to moderate
      asthma
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have stable (for 6 months) physician-diagnosed asthma with historical documentation of
             the diagnosis

          -  Must be receiving 1 of the following required inhaled asthma therapies listed below
             for at least the last 30 days; Only SABA, which is used as needed for rescue, or Low
             to medium doses of ICS (alone or in combination with LABA), used regularly as
             maintenance asthma therapy

          -  Demonstrate acceptable spirometry performance (ie, meet American Thoracic Society
             [ATS]/European Respiratory Society [ERS] acceptability/repeatability criteria

          -  Pre-bronchodilator FEV1 of ≥50 to <80% predicted normal value after withholding SABA
             ≥6 hours

          -  Confirmed FEV1 reversibility to Ventolin, defined as a post-Ventolin increase in FEV1
             of ≥15%

          -  Only 2 reversibility testing attempts are allowed

        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)

          -  Oral corticosteroid use (any dose) within 6 weeks

          -  Received any marketed (eg, omalizumab, mepolizumab, reslizumab) or investigational
             biologic within 3 months or 5 half-lives, whichever is longer, or any other medication
             specifically prohibited by the protocol

          -  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)

          -  Life-threatening asthma as defined as any history of significant asthma episode(s)
             requiring intubation associated with hypercapnia, respiratory arrest, hypoxic
             seizures, or asthma-related syncopal episode(s)

          -  Historical or current evidence of a clinically significant disease

          -  Cancer not in complete remission for at least 5 years

          -  Hospitalized for psychiatric disorder or attempted suicide within 1 year

          -  Unable to abstain from protocol-defined prohibited medications during the study