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

Condition(s) targeted: Asthma

Intervention: Epinephrine inhalation aerosol (Drug); Placebo (Drug); epinephrine inhalation aerosol (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Amphastar Pharmaceuticals, Inc.

Overall contact:
Safety Monitor, Phone: (626) 459-5523

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

Secondary outcome:

Monitor vital signs

Cardiac rhythm

Blood glucose and potassium

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

Criteria:

Inclusion Criteria:

- 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.

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.

Safety Monitor, Phone: (626) 459-5523

West Coast Clinical Trials, Costa Mesa, California 92626, United States; Recruiting
Safety Monitor

Southern California Institute for Respiratory Diseases, Los Angeles, California 90048, United States; Recruiting
Safety Monitor

Asthma and Allergy Associates of Southern California, Mission Viejo, California 92691, United States; Recruiting
Safety Monitor

CHOC PSF, Division of Allergy, Asthma and Immunology, Orange, California 92868, United States; Recruiting
Safety Monitor

Allergy & Asthma Assocaites of Santa Clara Valley, San Jose, California 95117, United States; Recruiting
Safety Monitor

Bensch Research Associates, Stockton, California 95207, United States; Recruiting
Safety Monitor

Colorado Allergy & Asthma Centers, Centennial, Colorado 80112, United States; Recruiting
Safety Monitor

Colorado Allergy & Asthma Centers, Denver, Colorado 80230, United States; Recruiting
Safety Monitor

Rocky Mountain Center for Clinical Research, Wheat Ridge, Colorado 80033, United States; Recruiting
Safety Monitor

Atlanta Allergy & Asthma Clinic, Woodstock, Georgia 30188, United States; Recruiting
Safety Monitor

Iowa Clinical Research Corporation, Iowa City, Iowa 52240, United States; Recruiting
Safety Monitor

Family Allergy & Asthma Research Institute, Louisville, Kentucky 40215, United States; Recruiting
Safety Monitor

Northeast Medical Research Associates, No. Dartmouth, Massachusetts 02747, United States; Recruiting
Safety Monitor

Clinical Research Institute, Minneapolis, Minnesota 55402, United States; Recruiting
Safety Monitor

Clinical Research Institute, Plymouth, Minnesota 55441, United States; Recruiting
Safety Monitor

The Clinical Research Center, St. Louis, Missouri 63141, United States; Recruiting
Safety Monitor

Clinical Research Group of Montana, Bozeman, Montana 59718, United States; Recruiting
Safety Monitor

The Asthma & Allergy Center, Bellevue, Nebraska 68123, United States; Recruiting
Safety Monitor

Princeton Center for Clinical Research, Skillman, New Jersey 08558, United States; Recruiting
Safety Monitor

North Carolina Clinical Research, Raleigh, North Carolina 27607, United States; Recruiting
Safety Monitor

New Horizons Clinical Research, Cincinnati, Ohio 45242, United States; Recruiting
Safety Monitor

Intergated Medical Research, Ashland, Oregon 97520, United States; Recruiting
Safety Monitor

Allergy and Asthma Research Group, Eugene, Oregon 97401, United States; Recruiting
Safety Monitor

Baker Allergy, Asthma & Dermatology Research Center, Lake Oswego, Oregon 97035, United States; Recruiting
Safety Monitor

The Clinical Research Institute of Southern Oregon, Medford, Oregon 97504, United States; Recruiting
Safety Monitor

Transitional Clinical Research, Portland, Oregon 97213, United States; Recruiting
Safety Monitor

Allergy and Clinical Immunology Associates, Pittsburg, Pennsylvania 15241, United States; Recruiting
Safety Monitor

Asthma & Allergy Research Associates, Upland, Pennsylvania 17013, United States; Recruiting
Safety Monitor

National Allergy, Asthma & Urticaria Centers of Charleston, Charleston, South Carolina 29406, United States; Recruiting
Safety Monitor

Western Sky Research, El Paso, Texas 79903, United States; Recruiting
Safety Monitor

Central Texas Health Research, New Braunfels, Texas 78130, United States; Recruiting
Safety Monitor

Sylvana Research Associates, San Antonio, Texas 78229, United States; Recruiting
Safety Monitor

Allergy Partners, Richmond, Virginia 23229, United States; Recruiting
Safety Monitor

ASTHMA, Inc., Seattle, Washington 98105, United States; Recruiting
Safety Monitor

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: July 7, 2011