Safety Study in Adolescent and Adult Patients With Asthma

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: 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 3
• Accepts Healthy Volunteers?: No

Details

• 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