E004-C2 is a continuation of E004-C for safety evaluations with additional 3 months to be able to assess the 6-month safety profile for E004 (epinephrine inhalation) versus placebo in a double-blinded manner.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
208
0 mcg/inhalation, 2 inhalations QID
220 mcg/inhalation, 2 inhalations QID
125 mcg/inhalation, 2 inhalations QID
Amphastar Site 0006
Costa Mesa, California, United States
Adverse Events
Recording of all adverse events experienced during the course of the study
Time frame: up to 12 weeks
Change in 12 lead ECG including QT/QTc analysis
A 12-lead ECG (routine and QT/QTc) will be measured and recorded, provided that dosing of study drug has been performed greater than 1 hour prior to conducting the measurements.
Time frame: Study visit 4, 8 and 12, greater than one hour after last dose
Asthma Exacerbations
Review use of resuce inhaler for treatment of asthma exacrbations occuring between doses of study medication.
Time frame: up to 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Amphastar Site 0005
Los Angeles, California, United States
Amphastar Site 0004
Orange, California, United States
Amphastar Site 0001
San Jose, California, United States
Amphastar Site 0003
Stockton, California, United States
Amphastar Site 0008
Denver, Colorado, United States
Amphastar Site 0009
Wheat Ridge, Colorado, United States
Amphastar Site 0011
Iowa City, Iowa, United States
Amphastar Site 0013
North Dartmouth, Massachusetts, United States
Amphastar Site 0014
Minneapolis, Minnesota, United States
...and 17 more locations