CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
epinephrine inhalation aerosol +2 moredrug
Likely dose
epinephrine inhalation aerosol 220 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/NCT01143051
NCT01143051Phase 2Completed
CompareCT.gov

Phase I/II Study Epinephrine Inhalation Aerosol USP, an HFA-MDI Clinical Study-B for Assessment of Pharmacokinetics

Amphastar Pharmaceuticals, Inc.·interventional·Posted Jun 14, 2010·Updated Sep 25, 2018

In Brief

A Phase 2 clinical trial evaluating epinephrine inhalation aerosol for Asthma. Completed, enrolled 24 participants across 1 site.

Detailed Summary

This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), in healthy male and female adult volunteers. Safety of E004 will also be evaluated, under augmented dose conditions.

Study Details

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

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 14, 2010
Enrollment StartJan 1, 2010
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.1 years ago

Interventions

epinephrine inhalation aerosoldrug

Single dose 220 mcg/inhalation, 10 inhalations

epinephrine inhalation aerosoldrug

HFA propelled epinephrine inhalation aerosol, 125 mcg/inhalation, 10 inhalations

epinephrine inhalation aerosoldrug

HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation, 10 inhalations