A repeat-dose thorough QT study of inhaled fluticasone furoate/vilanterol combination in healthy subjects.

ABSTRACT:

Aims

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.

Methods

This was a randomized, placebo- and positive-controlled, double-dummy, double-blind, four-way crossover study, in which healthy subjects (n = 85) were randomized to 7 days of once-daily treatment of FF/VI (200/25 or 800/100 μg) or placebo or single-dose oral moxifloxacin (single-blind, 400 mg). In the supportive TQT study, subjects (n = 40) were randomized to single-dose inhaled FF (4000 μg), oral moxifloxacin (400 mg) or placebo.

Results

There was a lack of effect of FF/VI (200/25 μg) on QTcF (Fridericia's correction); all time-matched mean diff

SUBMITTER: Kempsford R 

PROVIDER: S-EPMC3952721 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature