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Completed Phase 3 Interventional

Evaluation of Efficacy and Safety of E004 in Children With Asthma

ClinicalTrials.gov ID: NCT01460511

Public ClinicalTrials.gov record NCT01460511. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 9:58 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase III Study of Epinephrine Inhalation Aerosol for Evaluation of Efficacy and Safety of E004 in Children With Asthma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01460511
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Amphastar Pharmaceuticals, Inc.
Industry
Enrollment
70 participants

Conditions and interventions

Eligibility (public fields only)

Age range
4 Years to 11 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 2011 (Type not available)
Primary completion
Mar 2012 (Actual)
Completion
Jul 2012 (Actual)
Last update posted
Jul 31, 2018

2011 – 2012

United States locations

U.S. sites
8
U.S. states
4
U.S. cities
8
Facility City State ZIP Site status
Amphastar Site 5 Costa Mesa California 92626 —
Amphastar Site 8 Orange California 92868 —
Amphastar Site 4 Stockton California 95207 —
Amphastar Site 2 Medford Oregon 97504 —
Amphastar Site 1 Portland Oregon 97202 —
Amphastar Site 7 North Charleston South Carolina 29406 —
Amphastar Site 3 El Paso Texas 79903 —
Amphastar Site 6 San Antonio Texas 78229 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01460511, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 31, 2018 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01460511 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →