New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day

A 12-week, Double-blind, Randomized, Multi-centre, Parallel-group Study Evaluating the Efficacy Safety, and Patient Use (User Study) of Symbicort® (Budesonide/Formoterol) Breath Actuated Metered Dose Inhaler (BA MDI) 2x160/4.5 μg Twice Daily Compared With Symbicort (Budesonide/Formoterol) AC (Actuation Counter) pMDI® 2x160/4.5 μg Twice Daily and Budesonide AC pMDI 2x160 μg Twice Daily in Adult and Adolescent Asthmatics

This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.

Inclusion Criteria:

• Male or female 12 years and above
• Clinical diagnosis of asthma according to the American Thoracic Society definition at least 6 months
• Pre-bronchodilator FEV1 ≥ 45% and ≤ 85% of predicted normal
• Patients with reversible airway obstruction
• Documented daily use of inhaled corticosteroids for ≥ 3 months

Exclusion Criteria:

• History of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures during the 2 years prior to Visit 2
• Hospitalized during previous 6 months for asthma
• Required emergency treatment more than once during previous 6 months for an asthma-related condition
• Intake of oral, rectal or parenteral glucocorticosteroid within 30 days of enrolment
• Respiratory infection affecting the asthma within 30 days