Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

This clinical study evaluates the 12-week efficacy and safety of Epinephrine HFA Inhalation Aerosol HFA the proposed HFA formulation of metered dose inhaler (MDI) of Epinephrine, in comparison to a Placebo-HFA control MDI and the currently marketed Primatene® Mist (epinephrine CFC inhaler), in adolescent and adult subjects with asthma.

Key facts

Study ID

NCT01357642

Run by

Amphastar Pharmaceuticals, Inc.

People needed

373

Starts

2011-07-01

Expected to finish

2011-12-01

Last updated by the study team

2016-03-11

Who can join

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

You may qualify if…

• 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
• Can tolerate withholding treatment with inhaled bronchodilators and other allowed medications for the minimum washout period.
• Demonstrating a Screening Baseline FEV1 that is 50 - 90% of predicted normal value.
• Demonstrating at least a 12% Airway Reversibility.
• 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

• West Coast Clinical Trials — Costa Mesa, California, United States
• Southern California Institute for Respiratory Diseases — Los Angeles, California, United States
• Asthma and Allergy Associates of Southern California — Mission Viejo, California, United States
• CHOC PSF, Division of Allergy, Asthma and Immunology — Orange, California, United States
• Allergy & Asthma Assocaites of Santa Clara Valley — San Jose, California, United States
• Colorado Allergy & Asthma Centers — Centennial, Colorado, United States
• Colorado Allergy & Asthma Centers — Denver, Colorado, United States
• Rocky Mountain Center for Clinical Research — Wheat Ridge, Colorado, United States
• Atlanta Allergy & Asthma Clinic — Woodstock, Georgia, United States
• Iowa Clinical Research Corporation — Iowa City, Iowa, United States
• Family Allergy & Asthma Research Institute — Louisville, Kentucky, United States
• Northeast Medical Research Associates — No. Dartmouth, Massachusetts, United States
• Clinical Research Institute — Minneapolis, Minnesota, United States
• Clinical Research Institute — Plymouth, Minnesota, United States
• The Clinical Research Center — St Louis, Missouri, United States
• Clinical Research Group of Montana — Bozeman, Montana, United States
• The Asthma & Allergy Center — Bellevue, Nebraska, United States
• Princeton Center for Clinical Research — Skillman, New Jersey, United States
• North Carolina Clinical Research — Raleigh, North Carolina, United States
• New Horizons Clinical Research — Cincinnati, Ohio, United States
• Intergated Medical Research — Ashland, Oregon, United States
• Allergy and Asthma Research Group — Eugene, Oregon, United States
• Baker Allergy, Asthma & Dermatology Research Center — Lake Oswego, Oregon, United States
• The Clinical Research Institute of Southern Oregon — Medford, Oregon, United States
• Transitional Clinical Research — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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