Overview
Safety Study in Adolescent and Adult Patients With Asthma
Status:
Completed
Completed
Trial end date:
2012-07-01
2012-07-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Amphastar Pharmaceuticals, Inc.Treatments:
Epinephrine
Epinephryl borate
Racepinephrine
Criteria
Inclusion Criteria:- 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 Criteria:
- 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