This clinical study evaluates the 12-week efficacy and safety of Epinephrine HFA Inhalation Aerosol HFA the proposed HFA formulation of metered dose inhaler (MDI) of Epinephrine, in comparison to a Placebo-HFA control MDI and the currently marketed Primatene® Mist (epinephrine CFC inhaler), in adolescent and adult subjects with asthma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
373
Epinephrine inhalation aerosol, 125 mcg/inhalation, 2 inhalations QID at 4 - 6 hour intervals
Placebo for epinephrine inhalation aerosol, formulation without epinephrine
epinephrine inhalation aerosol, 220 mcg/inhalation, 2 inhalations QID at 4-6 hour intervals
Change in Area Under the Curve (AUC) versus placebo
Serial FEV1 measurements to demonstrate the mean AUC of change in percent FEV1 from same-day baseline of E004 (Treatment T; Epinephrine-HFA) versus Placebo-HFA (Treatment P) is the primary efficacy endpoint.
Time frame: at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose
Monitor vital signs
Assess blood pressure, pulse rate
Time frame: 2, 10, 20, 60, and 360 min after dosing
Cardiac rhythm
At study visits 1 and 5 only, perform 12 lead ECG
Time frame: at baseline, 2, 10, 20, and 60 min post-dose
Blood glucose and potassium
Monitor blood glucose and potassium levels to assure appropriate balance
Time frame: baseline, and at 15 and 120 min post-dose
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...and 23 more locations