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Trial record 26 of 39 for:    "Bronchial Disease" | "Epinephrine"

Safety Study in Adolescent and Adult Patients With Asthma

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.
 
ClinicalTrials.gov Identifier: NCT01476904
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Amphastar Pharmaceuticals, Inc.

Brief Summary:
E004-C2 is a continuation of E004-C for safety evaluations with additional 3 months to be able to assess the 6-month safety profile for E004 (epinephrine inhalation) versus placebo in a double-blinded manner.

Condition or disease Intervention/treatment Phase
Asthma Drug: Placebo Drug: Primatene Mist Drug: Epinephrine inhalation Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 3-month Safety Evaluation Extension to the 12-week E004-C Study in Asthma Patients (A Double Blinded, Placebo-controlled, Parallel, 3-month Safety Study in Adolescent and Adult Patients With Asthma)
Study Start Date : November 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Epinephrine

Arm Intervention/treatment
Experimental: Arm T
Arm T is the experimental treatment arm consisting of 2 x 125 mcg/inhalations of epinephrine inhalation, QID, with 4-6 hr intervals
Drug: Epinephrine inhalation
125 mcg/inhalation, 2 inhalations QID

Placebo Comparator: Arm P
Arm P is a placebo comparator consisting of 2× 0 mcg of placebo inhalations, QID, with 4-6 hr intervals
Drug: Placebo
0 mcg/inhalation, 2 inhalations QID

Active Comparator: Arm A
Arm A is an active comparator, Primatene Mist, consisting of 2× 220 mcg/inhalation, QID, with 4-6 hr intervals
Drug: Primatene Mist
220 mcg/inhalation, 2 inhalations QID




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: up to 12 weeks ]
    Recording of all adverse events experienced during the course of the study


Secondary Outcome Measures :
  1. Change in 12 lead ECG including QT/QTc analysis [ Time Frame: Study visit 4, 8 and 12, greater than one hour after last dose ]
    A 12-lead ECG (routine and QT/QTc) will be measured and recorded, provided that dosing of study drug has been performed greater than 1 hour prior to conducting the measurements.

  2. Asthma Exacerbations [ Time Frame: up to 12 weeks ]
    Review use of resuce inhaler for treatment of asthma exacrbations occuring between doses of study medication.



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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
Criteria

Inclusion Criteria:

  • Only subjects who have successfully completed the E004-C study within the last 135 days or those who are actively enrolled in the current study E004-C at the time of the study extension initiation
  • Male and female asthma patients aged 12 - 75 years
  • 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
  • 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 ClinicalTrials.gov identifier (NCT number): NCT01476904


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Locations
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United States, California
Amphastar Site 0006
Costa Mesa, California, United States, 92626
Amphastar Site 0005
Los Angeles, California, United States, 90048
Amphastar Site 0004
Orange, California, United States, 92868
Amphastar Site 0001
San Jose, California, United States, 95117
Amphastar Site 0003
Stockton, California, United States, 95207
United States, Colorado
Amphastar Site 0008
Denver, Colorado, United States, 80230
Amphastar Site 0009
Wheat Ridge, Colorado, United States, 80033
United States, Iowa
Amphastar Site 0011
Iowa City, Iowa, United States, 52240
United States, Massachusetts
Amphastar Site 0013
North Dartmouth, Massachusetts, United States, 02747
United States, Minnesota
Amphastar Site 0014
Minneapolis, Minnesota, United States, 55402
Amphastar Site 0015
Plymouth, Minnesota, United States, 55441
United States, Missouri
Amphastar Site 0016
St. Louis, Missouri, United States, 63141
United States, Montana
Amphastar Site 0017
Bozeman, Montana, United States, 59718
United States, Nebraska
Amphastar Site 0019
Bellevue, Nebraska, United States, 68123
United States, New Jersey
Amphastar Site 0020
Skillman, New Jersey, United States, 08558
United States, North Carolina
Amphastar Site 0018
Raleigh, North Carolina, United States, 27607
United States, Ohio
Amphastar Site 0021
Cincinnati, Ohio, United States, 45242
United States, Oregon
Amphastar Site 0024
Ashland, Oregon, United States, 97520
Amphastar Site 0022
Eugene, Oregon, United States, 97401
Amphastar Site 0023
Lake Oswego, Oregon, United States, 97035
Amphastar Site 0025
Medford, Oregon, United States, 97504
Amphastar Site 0026
Portland, Oregon, United States, 97202
United States, South Carolina
Amphastar Site 0029
North Charleston, South Carolina, United States, 29406
United States, Texas
Amphastar Site 0031
El Paso, Texas, United States, 79903
Amphastar Site 0030
New Braunfels, Texas, United States, 78130
United States, Virginia
Amphastar Site 0033
Richmond, Virginia, United States, 23229
United States, Washington
Amphastar Site 0034
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Amphastar Pharmaceuticals, Inc.
Investigators
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Study Director: Safety Monitor Amphastar Pharmaceuticals, Inc.

Publications:
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Responsible Party: Amphastar Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01476904     History of Changes
Other Study ID Numbers: API-E004-CL-C2
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Keywords provided by Amphastar Pharmaceuticals, Inc.:
Asthma
Bronchial Asthma
Shortness of breath
Additional relevant MeSH terms:
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Bronchial Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Asthma
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
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
Mydriatics
Sympathomimetics
Vasoconstrictor Agents