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