Evaluation of Efficacy and Safety of E004 in Children With Asthma



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:4 - 11
Updated:8/2/2018
Start Date:October 2011
End Date:July 2012

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Phase III Study of Epinephrine Inhalation Aerosol for 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.


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.
We found this trial at
8
sites
Costa Mesa, California 92626
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El Paso, Texas 79903
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Medford, Oregon 97504
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North Charleston, South Carolina 29406
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Orange, California 92868
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Portland, Oregon 97202
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Portland, OR
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San Antonio, Texas 78229
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Stockton, California 95207
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Stockton, CA
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