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

This study has been completed.
Sponsor:
Information provided by:
Amphastar Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01357642
First received: May 19, 2011
Last updated: January 23, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Asthma
Drug: Epinephrine inhalation aerosol
Drug: Placebo
Drug: epinephrine inhalation aerosol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Amphastar Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Change in Area Under the Curve (AUC) versus placebo [ Time Frame: at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose ] [ Designated as safety issue: No ]
    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:
  • Monitor vital signs [ Time Frame: 2, 10, 20, 60, and 360 min after dosing ] [ Designated as safety issue: Yes ]
    Assess blood pressure, pulse rate

  • Cardiac rhythm [ Time Frame: at baseline, 2, 10, 20, and 60 min post-dose ] [ Designated as safety issue: Yes ]
    At study visits 1 and 5 only, perform 12 lead ECG

  • Blood glucose and potassium [ Time Frame: baseline, and at 15 and 120 min post-dose ] [ Designated as safety issue: Yes ]
    Monitor blood glucose and potassium levels to assure appropriate balance


Enrollment: 373
Study Start Date: July 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357642

  Show 33 Study Locations
Sponsors and Collaborators
Amphastar Pharmaceuticals, Inc.
  More Information

Publications:
Responsible Party: Safety Monitor, Amphastar Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01357642     History of Changes
Other Study ID Numbers: API-E004-CL-C
Study First Received: May 19, 2011
Last Updated: January 23, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 27, 2014