Safety Study in Adolescent and Adult Patients With Asthma

Study Overview
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Brief Summary
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E004-C2 is a continuation of E004-C for safety evaluations with additional 3 months to be able to assess the 6-month safety profile for E004 (epinephrine inhalation) versus placebo in a double-blinded manner.

Official Title
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A 3-month Safety Evaluation Extension to the 12-week E004-C Study in Asthma Patients (A Double Blinded, Placebo-controlled, Parallel, 3-month Safety Study in Adolescent and Adult Patients With Asthma)

Conditions
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Asthma

Intervention / Treatment
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* Drug: Placebo
* Drug: Primatene Mist
* Drug: Epinephrine inhalation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Only subjects who have successfully completed the E004-C study within the last 135 days or those who are actively enrolled in the current study E004-C at the time of the study extension initiation Male and female asthma patients aged 12 - 75 years 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 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 epinephrine inhalation, QID, with 4-6 hr intervals | Drug: Epinephrine inhalation<br>* 125 mcg/inhalation, 2 inhalations QID<br>|
| Placebo Comparator: Arm P<br>Arm P is a placebo comparator consisting of 2× 0 mcg of placebo inhalations, QID, with 4-6 hr intervals | Drug: Placebo<br>* 0 mcg/inhalation, 2 inhalations QID<br>|
| Active Comparator: Arm A<br>Arm A is an active comparator, Primatene Mist, consisting of 2× 220 mcg/inhalation, QID, with 4-6 hr intervals | Drug: Primatene Mist<br>* 220 mcg/inhalation, 2 inhalations QID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Recording of all adverse events experienced during the course of the study | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 12 lead ECG including QT/QTc analysis | A 12-lead ECG (routine and QT/QTc) will be measured and recorded, provided that dosing of study drug has been performed greater than 1 hour prior to conducting the measurements. | Study visit 4, 8 and 12, greater than one hour after last dose | 
| Asthma Exacerbations | Review use of resuce inhaler for treatment of asthma exacrbations occuring between doses of study medication. | up to 12 weeks | 

 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