Asthma Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Two-way Crossover 7-day Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Repeat Dose Inhaled GW642444 25 μg (Micrograms) in Children Aged 5-11 Years With Persistent Asthma.
This study will investigate the effect of dosing paedeatric asthmatic subjects with GW642444, an orally inhaled long-acting agonist of the β2-adrenoceptor.
This study will investigate the effect of dosing with 25 μg GW642444, an orally inhaled
long-acting agonist of the β2-adrenoceptor, in asthmatic subjects aged 5 to 11. GW642444 is
currently under development as the long-acting beta-agonist component of a combination
product containing an inhaled corticosteroid and a longacting beta-agonist.
Subjects will receive a single dose via a novel dry powder inhaler, then 7 days once-daily
repeat dosing following a washout period. The study will be a randomized two-way crossover,
with a placebo control. Approximately 26 subjects will be recruited to this study, with the
aim that 20 will complete the study. Safety, tolerability, pharmacokinetics and glucose and
potassium levels will be investigated.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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