Evaluation of Efficacy and Safety of E004 in Children With Asthma

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.