Evaluation of Efficacy and Safety of E004 in Children With Asthma
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ClinicalTrials.gov Identifier: NCT01460511 |
Recruitment Status :
Completed
First Posted : October 27, 2011
Last Update Posted : July 31, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: E004 (Epinephrine Inhalation Aerosol) HFA-MDI Drug: Placebo-HFA | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 70 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Phase III Study of Epinephrine Inhalation Aerosol for Evaluation of Efficacy and Safety of E004 in Children With Asthma |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | March 2012 |
Actual Study Completion Date : | July 2012 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: P - Placebo-HFA
Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID
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Drug: Placebo-HFA
Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID |
Experimental: T - E004 (Epinephrine Inhalation Aerosol) HFA-MDI
E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID
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Drug: E004 (Epinephrine Inhalation Aerosol) HFA-MDI
E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID |
- 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%.
- 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

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Ages Eligible for Study: | 4 Years to 11 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT01460511
United States, California | |
Amphastar Site 5 | |
Costa Mesa, California, United States, 92626 | |
Amphastar Site 8 | |
Orange, California, United States, 92868 | |
Amphastar Site 4 | |
Stockton, California, United States, 95207 | |
United States, Oregon | |
Amphastar Site 2 | |
Medford, Oregon, United States, 97504 | |
Amphastar Site 1 | |
Portland, Oregon, United States, 97202 | |
United States, South Carolina | |
Amphastar Site 7 | |
North Charleston, South Carolina, United States, 29406 | |
United States, Texas | |
Amphastar Site 3 | |
El Paso, Texas, United States, 79903 | |
Amphastar Site 6 | |
San Antonio, Texas, United States, 78229 |
Study Chair: | John Gao, M.D. | Amphastar Pharmaceuticals, Inc. |
Responsible Party: | Amphastar Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT01460511 |
Other Study ID Numbers: |
API-E004-CL-D |
First Posted: | October 27, 2011 Key Record Dates |
Last Update Posted: | July 31, 2018 |
Last Verified: | July 2018 |
Mild bronchial asthma |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Epinephrine 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 |