There is a regulatory requirement to evaluate the extent of reduction (if any) of growth
velocity associated with inhaled corticosteroid (ICS) containing products that are to be
administered to children, and to this end there is Food and Drug Administration (FDA)
regulatory guidance. This is a randomised, single-blind (run-in period)/double-blind
(treatment period), parallel group, placebo controlled, multicentre study to assess the
effect of once daily (OD) inhaled fluticasone furoate (FF) 50 microgram (mcg) on growth
velocity in prepubertal asthmatic children on a background therapy of open-label montelukast.
This study will be conducted over a total duration of approximately 76 weeks: 16-week run-in
period (single-blind placebo inhaler), 52-week double-blind treatment period (inhaled FF 50
mcg /placebo administered OD in the morning for 52 weeks) and 8-week follow-up period. The
purpose of the study is to evaluate the magnitude of effect (with a level of precision) on
growth velocity of prepubertal asthmatic paediatric subjects (aged 5 to <9 years) following
administration of OD inhaled FF 50 mcg for one year. This study fulfills European Union (EU)
and United States (US) regulatory requirements for the evaluation of potential growth
suppression in children.