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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
373

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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