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

Recruitment & Eligibility

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

Study & Design

Arm && Interventions

Group	Intervention	Description
AS MDI	AS MDI	AS MDI 1+1+2+4+8 inhalations of 90 μg per inhalation
Proventil	Proventil	Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation

Primary Outcome Measures

Name	Time	Method
Baseline-adjusted FEV1 30 Minutes After Each Cumulative Dose	At the two study treatment visits, FEV1 (forced expiratory volume in 1 second) will be measured prior to drug administration and 5 times, once at 30 minutes after each of the 5 doses	Forced expiratory volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation

Secondary Outcome Measures

Name	Time	Method
Baseline-adjusted FEV1 AUC0-6 After the Last Cumulative Dose	Over 6 hours post dose on Day 1	The baseline-adjusted FEV1 AUC0-6 is the area under the curve for change from baseline calculated using the trapezoidal rule and normalized by dividing the AUC by the length of follow up post the last cumulative dose (typically 6 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose) normalized for length of follow up).

Recruitment & Eligibility