Evaluation of Efficacy and Safety of E004 in Children With Asthma

Amphastar Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Placebo-HFA; Drug: E004 (Epinephrine Inhalation Aerosol) HFA-MDI

Study type: Interventional

Funder types: Industry

Identifiers

NCT01460511

API-E004-CL-D

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 4 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

P - Placebo-HFA

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo-HFA

T - E004 (Epinephrine Inhalation Aerosol) HFA-MDI

Experimental group

Description:

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

Treatment:

Drug: E004 (Epinephrine Inhalation Aerosol) HFA-MDI