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

Phase 3

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Patients with documented asthma, requiring inhaled epinephrine or beta 2-agonist treatment.
No significant changes in asthma therapy and no asthma-related hospitalization or emergency visits, within 4 weeks prior to Screening
Can tolerate withholding treatment with inhaled bronchodilators and other allowed medications for the minimum washout period.
Demonstrating a Screening Baseline FEV1 that is 50 - 90% of predicted normal value.
Demonstrating at least a 12% Airway Reversibility.
Demonstrating satisfactory techniques in the use of metered-dose inhaler and a hand held peak expiratory flow meter.
Female patients of child-bearing potential must be non-pregnant and non-lactating at Screening and throughout the study, and must use an acceptable method of contraception during the study.

Exclusion Criteria

A smoking history of 10-pack years, or having smoked within 12 months of screening.
Any current or past medical conditions that, per investigator discretion, might significantly affect responses to the study drugs, other than asthma.
Concurrent clinically significant diseases.
Known intolerance or hypersensitivity to any component of the study drugs.
Recent infection of the respiratory tract, before screening.
Use of prohibited medications.
Having been on other investigational drug/device studies in the last 30 days prior to screening.
Known or highly suspected substance abuse.

Arm && Interventions

Group	Intervention	Description
Arm A	epinephrine inhalation aerosol	Active comparator, Primatene Mist, 2×220 mcg/inhalation, QID, with 4-6 hr intervals
Arm T	epinephrine inhalation aerosol	Arm T is the experimental treatment arm consisting of 2 x 125 mcg/inhalations of E004, QID, with 4-6 hr intervals
Arm P	Placebo	Placebo comparator as 2×Placebo QID, with 4-6 hr intervals

Primary Outcome Measures

Name	Time	Method
Change in Area Under the Curve (AUC) versus placebo	at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose	Serial FEV1 measurements to demonstrate the mean AUC of change in percent FEV1 from same-day baseline of E004 (Treatment T; Epinephrine-HFA) versus Placebo-HFA (Treatment P) is the primary efficacy endpoint.

Secondary Outcome Measures

Name	Time	Method
Blood glucose and potassium	baseline, and at 15 and 120 min post-dose	Monitor blood glucose and potassium levels to assure appropriate balance
Monitor vital signs	2, 10, 20, 60, and 360 min after dosing	Assess blood pressure, pulse rate
Cardiac rhythm	at baseline, 2, 10, 20, and 60 min post-dose	At study visits 1 and 5 only, perform 12 lead ECG

Locations (31): West Coast Clinical Trials
🇺🇸
Costa Mesa, California, United States
Southern California Institute for Respiratory Diseases
🇺🇸
Los Angeles, California, United States
Asthma and Allergy Associates of Southern California
🇺🇸
Mission Viejo, California, United States
CHOC PSF, Division of Allergy, Asthma and Immunology
🇺🇸
Orange, California, United States
Allergy & Asthma Assocaites of Santa Clara Valley
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San Jose, California, United States
Colorado Allergy & Asthma Centers
🇺🇸
Denver, Colorado, United States
Rocky Mountain Center for Clinical Research
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Wheat Ridge, Colorado, United States
Atlanta Allergy & Asthma Clinic
🇺🇸
Woodstock, Georgia, United States
Iowa Clinical Research Corporation
🇺🇸
Iowa City, Iowa, United States
Family Allergy & Asthma Research Institute
🇺🇸
Louisville, Kentucky, United States
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West Coast Clinical Trials
🇺🇸Costa Mesa, California, United States