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

February 11, 2016 updated by: Amphastar Pharmaceuticals, Inc.

Epinephrine Inhalation Aerosol USP, an HFA-MDI: Clinical Study-C For Evaluation Of Efficacy And Safety In Asthma Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

373

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Costa Mesa, California, United States, 92626
        • West Coast Clinical Trials
      • Los Angeles, California, United States, 90048
        • Southern California Institute for Respiratory Diseases
      • Mission Viejo, California, United States, 92691
        • Asthma and Allergy Associates of Southern California
      • Orange, California, United States, 92868
        • CHOC PSF, Division of Allergy, Asthma and Immunology
      • San Jose, California, United States, 95117
        • Allergy & Asthma Assocaites of Santa Clara Valley
    • Colorado
      • Centennial, Colorado, United States, 80112
        • Colorado Allergy & Asthma Centers
      • Denver, Colorado, United States, 80230
        • Colorado Allergy & Asthma Centers
      • Wheat Ridge, Colorado, United States, 80033
        • Rocky Mountain Center for Clinical Research
    • Georgia
      • Woodstock, Georgia, United States, 30188
        • Atlanta Allergy & Asthma Clinic
    • Iowa
      • Iowa City, Iowa, United States, 52240
        • Iowa Clinical Research Corporation
    • Kentucky
      • Louisville, Kentucky, United States, 40215
        • Family Allergy & Asthma Research Institute
    • Massachusetts
      • No. Dartmouth, Massachusetts, United States, 02747
        • Northeast Medical Research Associates
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Research Institute
      • Plymouth, Minnesota, United States, 55441
        • Clinical Research Institute
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • The Clinical Research Center
    • Montana
      • Bozeman, Montana, United States, 59718
        • Clinical Research Group of Montana
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • The Asthma & Allergy Center
    • New Jersey
      • Skillman, New Jersey, United States, 08558
        • Princeton Center for Clinical Research
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • North Carolina Clinical Research
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • New Horizons Clinical Research
    • Oregon
      • Ashland, Oregon, United States, 97520
        • Intergated Medical Research
      • Eugene, Oregon, United States, 97401
        • Allergy and Asthma Research Group
      • Lake Oswego, Oregon, United States, 97035
        • Baker Allergy, Asthma & Dermatology Research Center
      • Medford, Oregon, United States, 97504
        • The Clinical Research Institute of Southern Oregon
      • Portland, Oregon, United States, 97213
        • Transitional Clinical Research
    • Pennsylvania
      • Pittsburg, Pennsylvania, United States, 15241
        • Allergy and Clinical Immunology Associates
      • Upland, Pennsylvania, United States, 17013
        • Asthma & Allergy Research Associates
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • National Allergy, Asthma & Urticaria Centers of Charleston
    • Texas
      • El Paso, Texas, United States, 79903
        • Western Sky Research
      • New Braunfels, Texas, United States, 78130
        • Central Texas Health Research
      • San Antonio, Texas, United States, 78229
        • Sylvana Research Associates
    • Virginia
      • Richmond, Virginia, United States, 23229
        • Allergy Partners
    • Washington
      • Seattle, Washington, United States, 98105
        • ASTHMA, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm T
Arm T is the experimental treatment arm consisting of 2 x 125 mcg/inhalations of E004, QID, with 4-6 hr intervals
Drug: Epinephrine inhalation aerosol
Epinephrine inhalation aerosol, 125 mcg/inhalation, 2 inhalations QID at 4 - 6 hour intervals
Other Names:
  • epinephrine inhalation aerosol - HFA propelled
Placebo Comparator: Arm P
Placebo comparator as 2×Placebo QID, with 4-6 hr intervals
Drug: Placebo
Placebo for epinephrine inhalation aerosol, formulation without epinephrine
Active Comparator: Arm A
Active comparator, Primatene Mist, 2×220 mcg/inhalation, QID, with 4-6 hr intervals
Drug: epinephrine inhalation aerosol
epinephrine inhalation aerosol, 220 mcg/inhalation, 2 inhalations QID at 4-6 hour intervals
Other Names:
  • Primatene Mist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Area Under the Curve (AUC) versus placebo
Time Frame: at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose
Serial FEV1 measurements to demonstrate the mean AUC of change in percent FEV1 from same-day baseline of E004 (Treatment T; Epinephrine-HFA) versus Placebo-HFA (Treatment P) is the primary efficacy endpoint.
at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monitor vital signs
Time Frame: 2, 10, 20, 60, and 360 min after dosing
Assess blood pressure, pulse rate
2, 10, 20, 60, and 360 min after dosing
Cardiac rhythm
Time Frame: at baseline, 2, 10, 20, and 60 min post-dose
At study visits 1 and 5 only, perform 12 lead ECG
at baseline, 2, 10, 20, and 60 min post-dose
Blood glucose and potassium
Time Frame: baseline, and at 15 and 120 min post-dose
Monitor blood glucose and potassium levels to assure appropriate balance
baseline, and at 15 and 120 min post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amphastar Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

May 19, 2011

First Submitted That Met QC Criteria

May 20, 2011

First Posted (Estimate)

May 23, 2011

Study Record Updates

Last Update Posted (Estimate)

March 11, 2016

Last Update Submitted That Met QC Criteria

February 11, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • API-E004-CL-C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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