Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients
Information source: Amphastar Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Epinephrine inhalation aerosol (Drug); Placebo (Drug); epinephrine inhalation aerosol (Drug)
Phase: Phase 3
Sponsored by: Amphastar Pharmaceuticals, Inc.
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.
Official title: Epinephrine Inhalation Aerosol USP, an HFA-MDI: Clinical Study-C For Evaluation Of Efficacy And Safety In Asthma Patients
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in Area Under the Curve (AUC) versus placebo
Monitor vital signs
Blood glucose and potassium
Minimum age: 12 Years.
Maximum age: 75 Years.
- Patients with documented asthma, requiring inhaled epinephrine or beta 2-agonist
- 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.
- 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
- Known or highly suspected substance abuse.
Locations and Contacts
West Coast Clinical Trials, Costa Mesa, California 92626, United States
Southern California Institute for Respiratory Diseases, Los Angeles, California 90048, United States
Asthma and Allergy Associates of Southern California, Mission Viejo, California 92691, United States
CHOC PSF, Division of Allergy, Asthma and Immunology, Orange, California 92868, United States
Allergy & Asthma Assocaites of Santa Clara Valley, San Jose, California 95117, United States
Colorado Allergy & Asthma Centers, Centennial, Colorado 80112, United States
Colorado Allergy & Asthma Centers, Denver, Colorado 80230, United States
Rocky Mountain Center for Clinical Research, Wheat Ridge, Colorado 80033, United States
Atlanta Allergy & Asthma Clinic, Woodstock, Georgia 30188, United States
Iowa Clinical Research Corporation, Iowa City, Iowa 52240, United States
Family Allergy & Asthma Research Institute, Louisville, Kentucky 40215, United States
Northeast Medical Research Associates, No. Dartmouth, Massachusetts 02747, United States
Clinical Research Institute, Minneapolis, Minnesota 55402, United States
Clinical Research Institute, Plymouth, Minnesota 55441, United States
The Clinical Research Center, St. Louis, Missouri 63141, United States
Clinical Research Group of Montana, Bozeman, Montana 59718, United States
The Asthma & Allergy Center, Bellevue, Nebraska 68123, United States
Princeton Center for Clinical Research, Skillman, New Jersey 08558, United States
North Carolina Clinical Research, Raleigh, North Carolina 27607, United States
New Horizons Clinical Research, Cincinnati, Ohio 45242, United States
Intergated Medical Research, Ashland, Oregon 97520, United States
Allergy and Asthma Research Group, Eugene, Oregon 97401, United States
Baker Allergy, Asthma & Dermatology Research Center, Lake Oswego, Oregon 97035, United States
The Clinical Research Institute of Southern Oregon, Medford, Oregon 97504, United States
Transitional Clinical Research, Portland, Oregon 97213, United States
Allergy and Clinical Immunology Associates, Pittsburg, Pennsylvania 15241, United States
Asthma & Allergy Research Associates, Upland, Pennsylvania 17013, United States
National Allergy, Asthma & Urticaria Centers of Charleston, Charleston, South Carolina 29406, United States
Western Sky Research, El Paso, Texas 79903, United States
Central Texas Health Research, New Braunfels, Texas 78130, United States
Sylvana Research Associates, San Antonio, Texas 78229, United States
Allergy Partners, Richmond, Virginia 23229, United States
ASTHMA, Inc., Seattle, Washington 98105, United States
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Starting date: July 2011
Last updated: January 23, 2012