This is a randomized, double-blind, single-dose, placebo-controlled, 5-period, 5-treatment, crossover, multi-center study to assess the bronchodilatory effect and safety of 2 dose levels of Albuterol Sulfate Pressurized Inhalation Suspension (hereafter referred to as AS MDI), 90 μg and 180 μg, compared with placebo for AS MDI (hereafter referred to as Placebo MDI) and open-label Proventil® hydrofluoroalkane (HFA; hereafter referred to as Proventil) 90 μg and 180 μg in adult and adolescent subjects with mild to moderate asthma. This study design utilizes 10 treatment sequences.
This is a 5-period crossover study. Each Treatment Period is 1 day. Subjects will receive a single dose of randomized study drug at each of the 5 Treatment Visits (Visits 2, 3, 4, 5, and 6), with a 3- to 7-day Washout Period between Treatment Visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
86
AS MDI 90 μg (2 actuations of 45 μg/actuation)
AS MDI 180 μg (2 actuations of 90 μg/actuation)
Placebo MDI (2 actuations)
Proventil 90 μg (1 actuation of 90 μg/actuation)
Proventil 180 μg (2 actuations of 90 μg/actuation)
Research Site
Rolling Hills Estates, California, United States
Research Site
Stockton, California, United States
Research Site
Winter Park, Florida, United States
Research Site
North Dartmouth, Massachusetts, United States
Research Site
St Louis, Missouri, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Medford, Oregon, United States
Research Site
Spartanburg, South Carolina, United States
Research Site
El Paso, Texas, United States
Change From Baseline in FEV1 AUC0-6
Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-6 (Area under the curve from 0 to 6 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose) normalized for length of follow up.
Time frame: Over 6 hours post dose on Day 1
Change From Baseline in FEV1 AUC0-4
Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-4 (Area under the curve from 0 to 4 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose) normalized for length of follow up.
Time frame: Over 4 hours post dose on Day 1
Peak Change From Baseline in FEV1
Peak Change from baseline in FEV1 (Forced expiratory volume in 1 second)
Time frame: Over 6 hours post dose on Day 1
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