Summary:
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 prior to any study
- Male or Female, ≥18 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
- Patient has not had a history of life-threatening asthma that required intubation.
- Patient has not required treatment with systemic corticosteroids (tablets, suspensions or injectable) for any reason within 4 weeks prior to Visit 2
- Patient has does not an ongoing flair up of asthma, defined as a worsening of asthma that requires treatment with systemic corticosteroids (tablets, suspension, or injectable)
- An asthma flair up within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months prior to randomization or more than 2 hospitalizations for treatment of asthma in the 12 months prior to 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 have stable asthma.
- Peak expiratory flow must not be below 50% of predicted normal
- Pregnancy, breast-feeding or planned pregnancy during the study
Qualified Participants May Receive:
Symbicort or Budesonide and rescue inhaler(albuterol).