British journal of clinical pharmacology
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Br J Clin Pharmacol · Mar 2014
Randomized Controlled Trial Comparative StudyA repeat-dose thorough QT study of inhaled fluticasone furoate/vilanterol combination in healthy subjects.
This study was designed as a thorough QT (TQT) study to evaluate the effects of fluticasone furoate (FF)/vilanterol (VI) in healthy subjects. Supportive data from a TQT study conducted with FF are also presented. ⋯ Repeat once-daily dosing of FF/VI (200/25 μg), which is the highest therapeutic strength used in phase III studies, is not associated with QTc prolongation in healthy subjects. Supratherapeutic strength FF/VI (800/100 μg) demonstrated a small transient effect on QTcF but not on QTci.