The main objective is to evaluate the bronchodilatory efficacy, safety and pharmacokinetic profiles of A006 (Albuterol Dry Powder Inhaler (DPI)), in comparison with those of an active control, Proventil-HFA (Albuterol Metered Dose Inhaler (MDI)), and a Placebo DPI in escalating and cumulative-doses up to 1440 mcg, eight (8) times of the proposed clinical dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
27
Albuterol DPI with 180 mcg Albuterol/inhalation
Placebo DPI with 0 mcg Albuterol/inhalation
Albuterol MDI with 90 mcg Albuterol/inhalation
Amphastar Site 0025
Medford, Oregon, United States
Amphastar Site 0026
Portland, Oregon, United States
Amphastar Site 0032
San Antonio, Texas, United States
Amphastar Site 0034
Seattle, Washington, United States
Bronchodilatory efficacy after the escalating and cumulative-doses, up to 1,440 mcg.
Area Under the Curve (AUC)0-t of percent change in Forced Expiratory Volume in 1 second (FEV1), which is defined as the area under curve of post-dose FEV1 percentage changes from the Pre-dose Baseline FEV1 (FEV10) versus time. Doses are at 0, 30, 60 and 90 min.
Time frame: -15 min predose, 15 min post dose 1, 2 and 3 and 15, 45, 90, 120, 180, 240, 360 min post dose 4
AUC0-t of change in FEV1
AUC of FEV1 volume post-dose changes (change in Volume) from the Pre-dose Baseline FEV1 (FEV10). Doses are at 0, 30, 60 and 90 min.
Time frame: -15, 15 min post 1, 2, and 3, and 15, 90, 120, 240, and 360min post dose 4
Time to onset
Time to onset of bronchodilatory effect, determined by linear interpolation as the point where FEV1 % change first reaches ≥ 12% from FEV10.
Time frame: 0 - 120 min
Peak Response
The peak bronchodilator response, defined as the maximum post-dose FEV1 % change. Doses are at time 0, 30, 60, and 90 min.
Time frame: 15 min post dose 1, 2 and 3 and 15, 45, 90, 120, 180, 240, and 360 min post dose 4
Adverse Events
The adverse drug events (ADE) that are observed with Proventil-HFA may be expected with the use of A006
Time frame: Time 0, 15, 45, 75, 105, 150, 195, 130, 190, 250, 435 minutes post dose 1
Blood Analysis
serum glucose and potassium analysis and PK analysis
Time frame: -15, 10, 25,40, 55, 70, 85, 95, 115, 145, 175, 210, 270, 330, 690 min post dose 1
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Vital Signs and Electrocardiogram (ECG)
vital signs, including pulse and blood pressure and 12-lead ECG
Time frame: -15, 5, 35, 65, 100, 155, 275, 455, 815 min post dose 1