A Dose-ranging Study of Fluticasone Furoate (FF)

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.