Safety Study in Adolescent and Adult Patients With Asthma

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01476904

Run by

Amphastar Pharmaceuticals, Inc.

People needed

208

Starts

2011-11-01

Expected to finish

2012-07-01

Last updated by the study team

2017-02-13

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Amphastar Site 0006 — Costa Mesa, California, United States
• 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
• Amphastar Site 0015 — Plymouth, Minnesota, United States
• Amphastar Site 0016 — St Louis, Missouri, United States
• Amphastar Site 0017 — Bozeman, Montana, United States
• Amphastar Site 0019 — Bellevue, Nebraska, United States
• Amphastar Site 0020 — Skillman, New Jersey, United States
• Amphastar Site 0018 — Raleigh, North Carolina, United States
• Amphastar Site 0021 — Cincinnati, Ohio, 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 0031 — El Paso, Texas, United States
• Amphastar Site 0030 — New Braunfels, Texas, United States

Full record on ClinicalTrials.gov

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