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Evaluation of Efficacy and Safety of E004 in Children 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: NCT01460511
Recruitment Status : Completed
First Posted : October 27, 2011
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Amphastar Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE October 24, 2011
First Posted Date  ICMJE October 27, 2011
Last Update Posted Date July 31, 2018
Study Start Date  ICMJE October 2011
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2011)
Primary Efficacy Endpoint AUC of FEV1's relative change [ Time Frame: Visit 1 and Visit 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose ]
bronchodilator effect expressed as AUC of FEV1's relative change (from the same day baseline) versus time, defined as AUC of ΔFEV1%.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2011)
  • AUC of FEV1 volume changes (AUC of change in FEV1) [ Time Frame: Visit 1 and Visit 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose ]
    determination of the change in FEV1 from baseline at visit to to post treatment at Visit 3
  • Maximum of change in FEV1% (Fmax) [ Time Frame: Visit 1 and Visit 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose ]
    Evaluation of maximum percent change in FEV1
  • Curves of change in FEV1, and change in FEV1%, versus time [ Time Frame: Visit 1 and Visit 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose ]
    Evaluation of curves of change in FEV1 and percent change in FEV1 over time
  • Time to onset of bronchodilator effect (to onset), determined the time point (within 60 minutes) where FEV1 first reaches ≥12% above Same-Day Baseline. [ Time Frame: Study Visits 1and 3 within 60 minutes post dose ]
    Evaluation of how much time elapses (within 60 minutes), until FEV1 first reaches ≥12% above Same-Day Baseline.
  • The time to peak FEV1 effect (tmax), defined as the time of Fmax. [ Time Frame: Study Visits 1 and 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose ]
    Evaluation of how much time elapses until FEV1 reaches its peak
  • Duration of efficacy (duration), defined as the total length of time when ΔFEV1% reaches and stays ≥12% above Same-Day Baseline. [ Time Frame: Study Weeks 1and 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose ]
    Evaluation of the total length of time it takes until the change in FEV1% reaches and stays ≥12% above Same-Day Baseline.
  • Percentage of positive responders (R%), including all subjects whose Fmax reaches ≥12% above Same-Day Baseline. [ Time Frame: Study Weeks 1 and 3 within 60 minutes post dose ]
    Evaluation of what percentage of subjects are positive responders (R%), including all subjects whose Fmaxreaches ≥12% above Same-Day Baseline.
  • Mean daily morning pre-dose Peak Expiratory Flow Rate (PEF) [ Time Frame: daily pre-dose ]
    Evaluation of the mean of daily morning pre-dose Expiratory Flow Rate
  • Evaluation of Vital Signs [ Time Frame: predose, and 3, 20, 60, 360 minutes post-dose ]
    Monitoring of vital signs (SBP/DBP, and heart rate) at the Screening Visit (Baseline and 30 min post-dose), and at the baseline, 3, 20, 60 and 360 minute time points during the study
  • 12-lead ECG [ Time Frame: Pre-dose and , 3, 20 and 60 minutes post-dose (Study Visits 1 and 3) ]
    Recording of 12-lead ECG (Routine and QT/QTc) at Screening Visit Baseline, and at the baseline, 3, 20 and 60 minute time points during Study Visits 1 and 3
  • Albuterol HFA usage for rescue relief of acute asthma symptoms [ Time Frame: Study Visits 1, 2, and 3, within 30 min predose ]
    Evaluation Albuterol HFA usage for rescue relief of acute asthma symptoms
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 Evaluation of Efficacy and Safety of E004 in Children With Asthma
Official Title  ICMJE Phase III Study of Epinephrine Inhalation Aerosol for Evaluation of Efficacy and Safety of E004 in Children With Asthma
Brief Summary This is a multi-center, randomized, double-blinded, placebo-controlled, parallel, 4-week study in 60 pediatric patients (4-11 years old) with asthma, comparing E004 with Placebo HFA-MDI in pediatric patients who are 4-11 years of age with asthma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: E004 (Epinephrine Inhalation Aerosol) HFA-MDI
    E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID
  • Drug: Placebo-HFA
    Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID
Study Arms  ICMJE
  • Placebo Comparator: P - Placebo-HFA
    Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID
    Intervention: Drug: Placebo-HFA
  • Experimental: T - E004 (Epinephrine Inhalation Aerosol) HFA-MDI
    E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID
    Intervention: Drug: E004 (Epinephrine Inhalation Aerosol) HFA-MDI
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2012)
70
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2011)
60
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Generally healthy male, and premenarchal female, children aged 4 - 11 years upon Screening.
  • With documented asthma, requiring inhaled epinephrine or beta2-agonist treatment, with or without concurrent anti-inflammatory therapies for at least 6-months prior to Screening.
  • Being capable of performing spirometry for FEV1
  • Satisfying criteria of asthma
  • Can tolerate withholding treatment with inhaled bronchodilators and other allowed medications for the minimum washout periods
  • Demonstrating a Screening Baseline FEV1 that is 50 - 90% of Polgar predicted normal value.
  • Demonstrating an Airway Reversibility,
  • Demonstrating satisfactory techniques in the use of a metered-dose inhaler (MDIs) and a hand held peak expiratory flow meter, after training.
  • Has been properly consented to participate in this study.

Exclusion Criteria:

  • Any current or past medical conditions that, per investigator discretion, might significantly affect pharmacodynamic responses to the study drugs
  • Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, or malignant diseases.
  • Known intolerance or hypersensitivity to any component of the study drugs
  • Recent infection of the respiratory tract
  • Use of prohibited medications
  • Having been on other investigational drug/device studies in the last 30 days prior to screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 11 Years   (Child)
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 NCT01460511
Other Study ID Numbers  ICMJE API-E004-CL-D
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 Chair: John Gao, M.D. Amphastar Pharmaceuticals, Inc.
PRS Account Amphastar Pharmaceuticals, Inc.
Verification Date July 2018

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