CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 70 enrolled
Drug / intervention
E004 (Epinephrine Inhalation Aerosol) HFA-MDI +1 moredrug
Likely dose
E004 (Epinephrine Inhalation Aerosol) HFA-MDI 125 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01460511
NCT01460511Phase 3Completed
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Phase III Study of Epinephrine Inhalation Aerosol for Evaluation of Efficacy and Safety of E004 in Children With Asthma

Amphastar Pharmaceuticals, Inc.·interventional·Posted Oct 27, 2011·Updated Jul 31, 2018

In Brief

A Phase 3 clinical trial evaluating E004 (Epinephrine Inhalation Aerosol) HFA-MDI and Placebo-HFA for Asthma. Completed, enrolled 70 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 27, 2011
Enrollment StartOct 1, 2011
Primary CompletionMar 1, 2012
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 14.7 years ago

Interventions

E004 (Epinephrine Inhalation Aerosol) HFA-MDIdrug

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

Placebo-HFAdrug

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