CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 373 enrolled
Drug / intervention
Epinephrine inhalation aerosol +2 moredrug
Likely dose
Epinephrine inhalation aerosol 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/NCT01357642
NCT01357642Phase 3Completed
CompareCT.gov

Epinephrine Inhalation Aerosol USP, an HFA-MDI: Clinical Study-C For Evaluation Of Efficacy And Safety In Asthma Patients

Amphastar Pharmaceuticals, Inc.·interventional·Posted May 23, 2011·Updated Mar 11, 2016

In Brief

A Phase 3 clinical trial evaluating Epinephrine inhalation aerosol, Placebo, and 1 other intervention for Asthma. Completed, enrolled 373 participants across 33 sites.

Detailed Summary

This clinical study evaluates the 12-week efficacy and safety of Epinephrine HFA Inhalation Aerosol HFA the proposed HFA formulation of metered dose inhaler (MDI) of Epinephrine, in comparison to a Placebo-HFA control MDI and the currently marketed Primatene® Mist (epinephrine CFC inhaler), in adolescent and adult subjects with asthma.

Study Details

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

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 23, 2011
Enrollment StartJul 1, 2011
Primary CompletionNov 1, 2011
Study CompletionDec 1, 2011
TodayJul 3, 2026
Enrollment to primary: 4 monthsPosted 15.1 years ago

Interventions

Epinephrine inhalation aerosoldrug

Epinephrine inhalation aerosol, 125 mcg/inhalation, 2 inhalations QID at 4 - 6 hour intervals

Placebodrug

Placebo for epinephrine inhalation aerosol, formulation without epinephrine

epinephrine inhalation aerosoldrug

epinephrine inhalation aerosol, 220 mcg/inhalation, 2 inhalations QID at 4-6 hour intervals