Safety Study in Adolescent and Adult Patients With Asthma

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