A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents

Inclusion Criteria:

• Provision of signed informed consent/ paediatric assent (if applicable) prior to any study specific procedures including medication withdrawal
• Male or Female, ≥12 years of age
• Documented clinical diagnosis of asthma for at least 1 year prior to Visit 2

• Patient must have history of at least 1 asthma exacerbation including one of the following:

  • requiring treatment with systemic corticosteroids
  • an asthma-related hospitalization between 4 weeks and 12 months prior to randomization
• Current Asthma Therapy: Patients must be appropriately using one of the treatments for asthma listed in the protocol combined with achieving certain results when recording an Asthma Control Questionnaire

Exclusion Criteria:

• Patient has a history of life-threatening asthma. Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support.
• Patient has required treatment with systemic corticosteroids (tablets, suspensions or injectable) for any reason within 4 weeks prior to Visit 2
• Patient has an ongoing exacerbation, defined as a worsening of asthma that requires treatment with systemic corticosteroids (tablets, suspension, or injectable)
• An asthma exacerbation within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization or more than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
• Patient has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 2 that, in the investigator's opinion, will interfere with the patient's lung function
• Patient must not meet unstable asthma severity criteria as listed in the protocol
• Peak expiratory flow must not be below 50% o predicted normal
• Pregnancy, breast-feeding or planned pregnancy during the study