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Completed Phase 3 Interventional

Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients

ClinicalTrials.gov ID: NCT01357642

Public ClinicalTrials.gov record NCT01357642. 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 Sep 6, 2026, 2:28 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

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

Brief summary

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

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 identification

NCT ID
NCT01357642
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Amphastar Pharmaceuticals, Inc.
Industry
Enrollment
373 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
12 Years to 75 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
Jun 30, 2011
Primary completion
Oct 31, 2011
Completion
Nov 30, 2011
Last update posted
Mar 10, 2016

2011

United States locations

U.S. sites
33
U.S. states
19
U.S. cities
33
Facility City State ZIP Site status
West Coast Clinical Trials Costa Mesa California 92626
Southern California Institute for Respiratory Diseases Los Angeles California 90048
Asthma and Allergy Associates of Southern California Mission Viejo California 92691
CHOC PSF, Division of Allergy, Asthma and Immunology Orange California 92868
Allergy & Asthma Assocaites of Santa Clara Valley San Jose California 95117
Colorado Allergy & Asthma Centers Centennial Colorado 80112
Colorado Allergy & Asthma Centers Denver Colorado 80230
Rocky Mountain Center for Clinical Research Wheat Ridge Colorado 80033
Atlanta Allergy & Asthma Clinic Woodstock Georgia 30188
Iowa Clinical Research Corporation Iowa City Iowa 52240
Family Allergy & Asthma Research Institute Louisville Kentucky 40215
Northeast Medical Research Associates No. Dartmouth Massachusetts 02747
Clinical Research Institute Minneapolis Minnesota 55402
Clinical Research Institute Plymouth Minnesota 55441
The Clinical Research Center St Louis Missouri 63141
Clinical Research Group of Montana Bozeman Montana 59718
The Asthma & Allergy Center Bellevue Nebraska 68123
Princeton Center for Clinical Research Skillman New Jersey 08558
North Carolina Clinical Research Raleigh North Carolina 27607
New Horizons Clinical Research Cincinnati Ohio 45242
Intergated Medical Research Ashland Oregon 97520
Allergy and Asthma Research Group Eugene Oregon 97401
Baker Allergy, Asthma & Dermatology Research Center Lake Oswego Oregon 97035
The Clinical Research Institute of Southern Oregon Medford Oregon 97504
Transitional Clinical Research Portland Oregon 97213
Allergy and Clinical Immunology Associates Pittsburgh Pennsylvania 15241
Asthma & Allergy Research Associates Upland Pennsylvania 17013
National Allergy, Asthma & Urticaria Centers of Charleston Charleston South Carolina 29406
Western Sky Research El Paso Texas 79903
Central Texas Health Research New Braunfels Texas 78130
Sylvana Research Associates San Antonio Texas 78229
Allergy Partners Richmond Virginia 23229
ASTHMA, Inc. Seattle Washington 98105

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 NCT01357642, 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 Mar 10, 2016 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01357642 live on ClinicalTrials.gov.

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