A 3-period Crossover Study With GSK573719 as Monotherapy in Adult Subjects With Asthma
Status:
Completed
Trial end date:
2013-02-01
Target enrollment:
Participant gender:
Summary
This is a multi-national, randomized, double-blind, 3-period crossover, incomplete block
design to evaluate 5 once-daily and 2 twice-daily doses of GSK573719 in combination with
placebo. The study will explore the dose range of GSK573719 in asthmatic subjects who are
currently using non-ICS controller medications. Subjects will participate in the study for up
to a maximum of 14 weeks. At randomization subjects will be stratified by age to ensure
adequate exposure to GSK573719 throughout the expected age range. The primary endpoint will
be trough FEV1 obtained 24 hours after the last morning dose on Day 14 of each treatment
sequence.
A sub-group of subjects at selected sites (approximately 30% of the total population) will
have additional serial assessments for spirometry, ECG and Holter, and pharmacokinetic
sampling at the start and end of each treatment period. Safety assessments will include
monitoring for adverse events, laboratory tests, asthma symptom assessments and twice daily
PEF evaluation. Consenting subjects will have a blood sample taken for pharmacogenetic
analysis.