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

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.