Asthma
Conditions
Keywords
asthma, bronchial asthma, shortness of breath
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.
Interventions
Epinephrine inhalation aerosol, 125 mcg/inhalation, 2 inhalations QID at 4 - 6 hour intervals
DRUGPlacebo
Placebo for epinephrine inhalation aerosol, formulation without epinephrine
epinephrine inhalation aerosol, 220 mcg/inhalation, 2 inhalations QID at 4-6 hour intervals
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Blood glucose and potassium | baseline, and at 15 and 120 min post-dose | Monitor blood glucose and potassium levels to assure appropriate balance |
Countries
United States
Outcome results
None listed