A 12-Week Study in Asthmatic Children Ages 6 to <12 Years, Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared With Budesonide pMDI 80 μg

A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study
Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice
Daily, and Symbicort pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared with Budesonide pMDI
80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years with Asthma

Inclusion Criteria:

- Has a documented clinical diagnosis of asthma defined by the ATS for at least 6
months prior to Visit 2

- Have a morning pre-bronchodilator clinic FEV1 measured at least 6 hours after the
last dose of inhaled SABA and at least 48 hours after last dose of inhaled LABA of
60% to 100% of predicted normal

- Demonstrated reversibility of clinic FEV1 of ≥12% from pre -albuterol/salbutamol
level within 15 to 30 minutes after administration of a standard dose of
albuterol/salbutamol.

Exclusion Criteria:

- Have been hospitalized at least once or required emergency treatment more than once
for an asthma-related condition during the 6 months prior to Visit 1

- Have required treatment with systemic corticosteroids (eg, oral, parenteral, or
rectal) for any reason within the 6 weeks prior to Visit 1