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Completed

NCT Number: NCT01460511

Evaluation of Efficacy and Safety of E004 in Children With Asthma

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

4 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Amphastar Site 5, Costa Mesa, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

E004 (Epinephrine Inhalation Aerosol) HFA-MDI

Drug

E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID

Placebo-HFA

Drug

Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID

Primary outcomes

  1. 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%.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. 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

  9. 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

  10. 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

  11. 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

Sponsors and collaborators

Lead sponsor

Amphastar Pharmaceuticals, Inc.

Industry

Registry information

Official study title

Phase III Study of Epinephrine Inhalation Aerosol for Evaluation of Efficacy and Safety of E004 in Children With Asthma

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 27, 2011
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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