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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

Status: Completed

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.

Clinical Details

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

Secondary outcome:

Monitor vital signs

Cardiac rhythm

Blood glucose and potassium


Minimum age: 12 Years. Maximum age: 75 Years. Gender(s): Both.


Inclusion Criteria:

- 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. 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


- 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

Additional Information

Related publications:

Pinnas JL, Schachtel BP, Chen TM, Roseberry HR, Thoden WR. Inhaled epinephrine and oral theophylline-ephedrine in the treatment of asthma. J Clin Pharmacol. 1991 Mar;31(3):243-7.

Hendeles L, Marshik PL, Ahrens R, Kifle Y, Shuster J. Response to nonprescription epinephrine inhaler during nocturnal asthma. Ann Allergy Asthma Immunol. 2005 Dec;95(6):530-4.

Warren JB, Doble N, Dalton N, Ewan PW. Systemic absorption of inhaled epinephrine. Clin Pharmacol Ther. 1986 Dec;40(6):673-8.

Cripps A, Riebe M, Schulze M, Woodhouse R. Pharmaceutical transition to non-CFC pressurized metered dose inhalers. Respir Med. 2000 Jun;94 Suppl B:S3-9.

Dickinson BD, Altman RD, Deitchman SD, Champion HC. Safety of over-the-counter inhalers for asthma: report of the council on scientific affairs. Chest. 2000 Aug;118(2):522-6.

Simons FE, Gu X, Johnston LM, Simons KJ. Can epinephrine inhalations be substituted for epinephrine injection in children at risk for systemic anaphylaxis? Pediatrics. 2000 Nov;106(5):1040-4.

Starting date: July 2011
Last updated: January 23, 2012

Page last updated: August 20, 2015

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