Status:
COMPLETED
Safety Study in Adolescent and Adult Patients With Asthma
Lead Sponsor:
Amphastar Pharmaceuticals, Inc.
Conditions:
Asthma
Eligibility:
All Genders
12-75 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT01476904
Start Date
November 1 2011
End Date
July 1 2012
Last Update
February 13 2017
Active Locations (27)
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1
Amphastar Site 0006
Costa Mesa, California, United States, 92626
2
Amphastar Site 0005
Los Angeles, California, United States, 90048
3
Amphastar Site 0004
Orange, California, United States, 92868
4
Amphastar Site 0001
San Jose, California, United States, 95117