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Trial record 27 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. Identifier: NCT01476904
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : February 13, 2017
Information provided by (Responsible Party):
Amphastar Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE November 15, 2011
First Posted Date  ICMJE November 22, 2011
Last Update Posted Date February 13, 2017
Study Start Date  ICMJE November 2011
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2011)
Adverse Events [ Time Frame: up to 12 weeks ]
Recording of all adverse events experienced during the course of the study
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01476904 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2011)
  • 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.
  • Asthma Exacerbations [ Time Frame: up to 12 weeks ]
    Review use of resuce inhaler for treatment of asthma exacrbations occuring between doses of study medication.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Safety Study in Adolescent and Adult Patients With Asthma
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: Placebo
    0 mcg/inhalation, 2 inhalations QID
  • Drug: Primatene Mist
    220 mcg/inhalation, 2 inhalations QID
  • Drug: Epinephrine inhalation
    125 mcg/inhalation, 2 inhalations QID
Study Arms  ICMJE
  • 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
    Intervention: Drug: Epinephrine inhalation
  • Placebo Comparator: Arm P
    Arm P is a placebo comparator consisting of 2× 0 mcg of placebo inhalations, QID, with 4-6 hr intervals
    Intervention: Drug: Placebo
  • Active Comparator: Arm A
    Arm A is an active comparator, Primatene Mist, consisting of 2× 220 mcg/inhalation, QID, with 4-6 hr intervals
    Intervention: Drug: Primatene Mist
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2012)
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2011)
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01476904
Other Study ID Numbers  ICMJE API-E004-CL-C2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amphastar Pharmaceuticals, Inc.
Study Sponsor  ICMJE Amphastar Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Safety Monitor Amphastar Pharmaceuticals, Inc.
PRS Account Amphastar Pharmaceuticals, Inc.
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP