Evaluation of Efficacy and Safety of E004 in Children With Asthma

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amphastar Pharmaceuticals, Inc.
• Treatments: Epinephrine; Epinephryl borate; Racepinephrine

Criteria

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.