Safety Study in Adolescent and Adult Patients With Asthma
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT01476904
- Lead Sponsor
- Amphastar Pharmaceuticals, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 208
- Only subjects who have successfully completed the E004-C study within the last 135 days or those who are actively enrolled in the current study E004-C at the time of the study extension initiation
- Male and female asthma patients aged 12 - 75 years
- Patients with documented asthma, requiring inhaled epinephrine or beta 2-agonist treatment
- No significant changes in asthma therapy and no asthma-related hospitalization or emergency visits, within 4 weeks prior to Screening
- Demonstrating satisfactory techniques in the use of metered-dose inhaler and a hand held peak expiratory flow meter
- Female patients of child-bearing potential must be non-pregnant and non-lactating at Screening and throughout the study, and must use an acceptable method of contraception during the study
- A smoking history of 10-pack years, or having smoked within 12 months of screening
- Any current or past medical conditions that, per investigator discretion, might significantly affect responses to the study drugs, other than asthma
- Concurrent clinically significant diseases
- Known intolerance or hypersensitivity to any component of the study drugs
- Recent infection of the respiratory tract, before screening
- Use of prohibited medications
- Having been on other investigational drug/device studies in the last 30 days prior to screening
- Known or highly suspected substance abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm P Placebo Arm P is a placebo comparator consisting of 2× 0 mcg of placebo inhalations, QID, with 4-6 hr intervals Arm T Epinephrine inhalation Arm T is the experimental treatment arm consisting of 2 x 125 mcg/inhalations of epinephrine inhalation, QID, with 4-6 hr intervals Arm A Primatene Mist Arm A is an active comparator, Primatene Mist, consisting of 2× 220 mcg/inhalation, QID, with 4-6 hr intervals
- Primary Outcome Measures
Name Time Method Adverse Events up to 12 weeks Recording of all adverse events experienced during the course of the study
- Secondary Outcome Measures
Name Time Method Change in 12 lead ECG including QT/QTc analysis Study visit 4, 8 and 12, greater than one hour after last dose 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.
Asthma Exacerbations up to 12 weeks Review use of resuce inhaler for treatment of asthma exacrbations occuring between doses of study medication.
Trial Locations
- Locations (27)
Amphastar Site 0006
🇺🇸Costa Mesa, California, United States
Amphastar Site 0004
🇺🇸Orange, California, United States
Amphastar Site 0008
🇺🇸Denver, Colorado, United States
Amphastar Site 0014
🇺🇸Minneapolis, Minnesota, United States
Amphastar Site 0018
🇺🇸Raleigh, North Carolina, United States
Amphastar Site 0021
🇺🇸Cincinnati, Ohio, United States
Amphastar Site 0031
🇺🇸El Paso, Texas, United States
Amphastar Site 0030
🇺🇸New Braunfels, Texas, United States
Amphastar Site 0033
🇺🇸Richmond, Virginia, United States
Amphastar Site 0034
🇺🇸Seattle, Washington, United States
Amphastar Site 0017
🇺🇸Bozeman, Montana, United States
Amphastar Site 0013
🇺🇸North Dartmouth, Massachusetts, United States
Amphastar Site 0019
🇺🇸Bellevue, Nebraska, United States
Amphastar Site 0020
🇺🇸Skillman, New Jersey, United States
Amphastar Site 0024
🇺🇸Ashland, Oregon, United States
Amphastar Site 0022
🇺🇸Eugene, Oregon, United States
Amphastar Site 0023
🇺🇸Lake Oswego, Oregon, United States
Amphastar Site 0025
🇺🇸Medford, Oregon, United States
Amphastar Site 0026
🇺🇸Portland, Oregon, United States
Amphastar Site 0029
🇺🇸North Charleston, South Carolina, United States
Amphastar Site 0005
🇺🇸Los Angeles, California, United States
Amphastar Site 0003
🇺🇸Stockton, California, United States
Amphastar Site 0001
🇺🇸San Jose, California, United States
Amphastar Site 0016
🇺🇸St. Louis, Missouri, United States
Amphastar Site 0011
🇺🇸Iowa City, Iowa, United States
Amphastar Site 0015
🇺🇸Plymouth, Minnesota, United States
Amphastar Site 0009
🇺🇸Wheat Ridge, Colorado, United States