This is a randomized, double-blind, placebo-controlled, repeat dose, 2-period, incomplete
block, crossover, safety and pharmacokinetic (PK) study to evaluate 3 once-daily doses of
umeclidinium (GSK573719; UMEC) in adolescent asthma subjects aged 12 through 17 years,) who
are currently using asthma medications that do not contain inhaled corticosteroids (non-ICS).
The objectives are to investigate safety and tolerability, and PK after a 7-day (+2) repeat
once-daily dose of UMEC (15.6, 62.5, and 250 mcg) in asthmatic adolescent subjects. Safety
endpoints will include reported adverse events, vital signs, ECGs, clinical laboratory tests,
and rescue albuterol use. The PK endpoints will include serial PK (plasma and urine)
concentrations and derived parameters.
Twenty four subjects will be randomized to participate in the study for up to 7 weeks
(including: an initial screening visit, a 7 to 14-day run-in, and 2 treatment periods each of
7 (+2) day duration, with a washout period of 7-14 days between treatment periods). There
will be a Follow-up Visit approximately one week after the end of the second treatment
period. Subjects will refrain from using rescue medication for 4 hours prior to any clinic
visits, unless for emergency.
During each treatment period, study medication will be taken once in the morning until the
morning of Day 7 (+2 days) when subjects will return to the clinic for study assessments and
take the last dose of study medication. On Day 7 (+2), subjects will remain in the clinic
overnight for serial assessments (ECG, and PK plasma and urine samples over the 24-hours).