Asthma Clinical Trial
Official title:
A Randomised, Double-blind, Two-way Crossover Study to Investigate the Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma
This study will be conducted to evaluate the effect of once daily treatment with fluticasone
furoate (FF) on lower leg growth in pediatric subjects with persistent asthma by using
knemometry. Approximately 65 paediatric asthmatic subjects, aged 5 to 11 years (inclusive),
will be screened to achieve 60 randomised and 50 evaluable subjects. Subjects meeting the
eligibility criteria will enter the 2 week run-in period. After completing run-in period,
each subject will be randomly allocated to one of two treatment sequences: inhaled
fluticasone furoate followed by placebo or placebo followed by inhaled fluticasone furoate.
Each treatment will be administered via the ELLIPTA™ dry powder inhaler. The two treatment
periods will be separated by a two-week wash-out period. Subjects completing two treatment
period will enter into 7 days follow-up period. ARNUITY™ ELLIPTA (FF) is approved in the US
for adults and adolescents aged 12 and above.
ARNUITY and ELLIPTA are a registered trademarks of the GlaxoSmithKline group of companies.
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