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Evaluation of Efficacy and Safety of E004 in Children With Asthma | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT01460511•Amphastar Pharmaceuticals, Inc.

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.

Eligibility

Age

4 - 11 years

Sex

ALL

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.

Locations (8)

Amphastar Site 5

Costa Mesa, California, United States

Amphastar Site 8

Orange, California, United States

Amphastar Site 4

Stockton, California, United States

Amphastar Site 2

Medford, Oregon, United States

Amphastar Site 1

Portland, Oregon, United States

Amphastar Site 7

North Charleston, South Carolina, United States

Amphastar Site 3

El Paso, Texas, United States

Amphastar Site 6

San Antonio, Texas, United States

Key Dates

Start Date

October 1, 2011

Primary Completion Date

March 1, 2012

Completion Date

July 1, 2012

Last Updated

July 31, 2018

Enrollment

ACTUAL participants

Conditions

Asthma

Interventions

E004 (Epinephrine Inhalation Aerosol) HFA-MDI

DRUG

Placebo-HFA

DRUG

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

View study

RECRUITINGNA

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 31, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of Efficacy and Safety of E004 in Children With Asthma

Inclusion Criteria

Exclusion Criteria

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

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