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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01357642
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : March 11, 2016
Information provided by (Responsible Party):
Amphastar Pharmaceuticals, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Epinephrine inhalation aerosol Drug: Placebo Drug: epinephrine inhalation aerosol Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 373 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Epinephrine Inhalation Aerosol USP, an HFA-MDI: Clinical Study-C For Evaluation Of Efficacy And Safety In Asthma Patients
Study Start Date : July 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2011

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 Name: 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 Name: Primatene Mist

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Monitor vital signs [ Time Frame: 2, 10, 20, 60, and 360 min after dosing ]
    Assess blood pressure, pulse rate

  2. 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

  3. 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

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01357642

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Sponsors and Collaborators
Amphastar Pharmaceuticals, Inc.

Responsible Party: Amphastar Pharmaceuticals, Inc. Identifier: NCT01357642     History of Changes
Other Study ID Numbers: API-E004-CL-C
First Posted: May 23, 2011    Key Record Dates
Last Update Posted: March 11, 2016
Last Verified: February 2016

Keywords provided by Amphastar Pharmaceuticals, Inc.:
bronchial asthma
shortness of breath

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents