A Phase 3 interventional study of Epinephrine inhalation aerosol and Placebo in Asthma, sponsored by Amphastar Pharmaceuticals, Inc.. Completed at 33 sites in United States. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-03-11.
Sponsored by Amphastar Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
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.
4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.
This study's enrollment of 373 is above the median of 83 across 2,814 interventional studies indexed under Asthma.
Browse Asthma studies →Amphastar Pharmaceuticals, Inc. is the lead sponsor of 21 studies on the registry; none are open to participants now.
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Arm T is the experimental treatment arm consisting of 2 x 125 mcg/inhalations of E004, QID, with 4-6 hr intervals
Drug: Epinephrine inhalation aerosol
Placebo comparator as 2×Placebo QID, with 4-6 hr intervals
Drug: Placebo
Active comparator, Primatene Mist, 2×220 mcg/inhalation, QID, with 4-6 hr intervals
Drug: epinephrine inhalation aerosol
Epinephrine inhalation aerosol, 125 mcg/inhalation, 2 inhalations QID at 4 - 6 hour intervals
Also known as: epinephrine inhalation aerosol - HFA propelled
Placebo for epinephrine inhalation aerosol, formulation without epinephrine
epinephrine inhalation aerosol, 220 mcg/inhalation, 2 inhalations QID at 4-6 hour intervals
Also known as: Primatene Mist
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
The record gives a start of Jul 2011, a primary completion of Nov 2011 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Epinephrine
Amphastar Pharmaceuticals, Inc.