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

Study Overview
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Brief Summary
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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.

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

Conditions
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Asthma

Intervention / Treatment
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* Drug: Epinephrine inhalation aerosol
* Drug: Placebo
* Drug: epinephrine inhalation aerosol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm T<br>Arm T is the experimental treatment arm consisting of 2 x 125 mcg/inhalations of E004, QID, with 4-6 hr intervals | Drug: Epinephrine inhalation aerosol<br>* Epinephrine inhalation aerosol, 125 mcg/inhalation, 2 inhalations QID at 4 - 6 hour intervals<br>* Other names: epinephrine inhalation aerosol - HFA propelled;|
| Placebo Comparator: Arm P<br>Placebo comparator as 2×Placebo QID, with 4-6 hr intervals | Drug: Placebo<br>* Placebo for epinephrine inhalation aerosol, formulation without epinephrine<br>|
| Active Comparator: Arm A<br>Active comparator, Primatene Mist, 2×220 mcg/inhalation, QID, with 4-6 hr intervals | Drug: epinephrine inhalation aerosol<br>* epinephrine inhalation aerosol, 220 mcg/inhalation, 2 inhalations QID at 4-6 hour intervals<br>* Other names: Primatene Mist;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Area Under the Curve (AUC) versus placebo | 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. | at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, bronchial asthma, shortness of breath