This is a Phase IIb, multi-centre, stratified, randomised, double-blind, double-dummy,
parallel-group, placebo and active controlled study in children aged 5-11 years with
persistent uncontrolled asthma. Subjects meeting all of the inclusion criteria and none of
the exclusion criteria at the screening visit (Visit 1) will enter a four week run-in period
during which time they will continue their current medications. Visit 2 will occur two weeks
into the run-in period to allow a review of compliance with daily diary and run-in
medication. At Visit 3 (end of run-in/randomization visit), subjects meeting the eligibility
criteria who remain uncontrolled despite baseline therapy will be stratified based on pre
screening inhaled corticosteroid (ICS) use. Once stratified, subjects will be randomised to
the treatment phase of the study where they will receive one of five treatments for 12 weeks.
Approx 1200 subjects ages 5 to 11 will be screened to achieve 575 randomized for a total of
115 randomized/evaluable subjects per treatment arm. Subjects will attend on-treatment visits
at 2, 4, 8 and 12 weeks (Visits 4, 5, 6 and 7 respectively). A follow-up contact will be
performed one week after completing study medication. All subjects must attempt spirometry
measurements at Visits 1 and 3. For all subjects, a timed 24-hour urine collection for
urinary cortisol and creatinine excretion will be performed prior to randomization at Visit 2
and within 7 days prior to Visit 7. All subjects must perform PEF daily between visits 1 and
7. The primary endpoint will be change from baseline in pre-dose (i.e. dosing trough) PM PEF
from patient hand held electronic daily diary at Endpoint (Endpoint is defined as the mean
over the last 7 days of treatment). Safety assessments include adverse events, oropharyngeal
examinations, clinical chemistry, urinary cortisol, and vital signs.