Asthma
Conditions
Keywords
Asthma, Bronchial Asthma, Shortness of breath
Brief summary
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.
Interventions
DRUGPlacebo
0 mcg/inhalation, 2 inhalations QID
DRUGPrimatene Mist
220 mcg/inhalation, 2 inhalations QID
DRUGEpinephrine inhalation
125 mcg/inhalation, 2 inhalations QID
Sponsors
Amphastar Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | up to 12 weeks | Recording of all adverse events experienced during the course of the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 12 lead ECG including QT/QTc analysis | Study visit 4, 8 and 12, greater than one hour after last dose | 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. |
| Asthma Exacerbations | up to 12 weeks | Review use of resuce inhaler for treatment of asthma exacrbations occuring between doses of study medication. |
Countries
United States
Outcome results
None listed