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

A 26 week, randomized, double-blind, parallel-group, active controlled, multicenter,
multinational safety study evaluating the risk of serious asthma-related events during
treatment with Symbicort®, a fixed combination of inhaled corticosteroid (ICS) (budesonide)
and a long acting β2-agonist (LABA) (formoterol) as compared to treatment with ICS
(budesonide) alone in adult and adolescent (≥12 years of age) patients with asthma.

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