Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
201546, A Repeat-dose Study of Batefenterol/FF (GSK961081/GW685698) Compared With Placebo in the Treatment of COPD
Batefenterol inhalation powder is currently under development as a fixed-dose combination
with fluticasone furoate (FF) for the treatment of Chronic Obstructive Pulmonary Disease
(COPD).
The present study will administer batefenterol/FF (300/100 micrograms [mcg]) for the first
time to subjects with COPD, to investigate the safety and tolerability of the combination
compared with placebo, and to evaluate the pharmacokinetics and pharmacodynamics profiles of
the individual components when administered in combination.
This is a Phase IIa, multicenter, randomized, placebo-controlled, double-blind, parallel
group study. Subjects will be randomized (2:1) to one of the following double-blind treatment
groups:
Batefenterol/FF 300/100 mcg inhalation powder once daily, or matching placebo inhalation
powder once daily.
Subjects will self-administer the study treatments once daily (QD) in the morning for 42 days
via a multi-dose dry powder inhaler (DPI) which contains two blister strips. Additionally, an
inhaled short acting beta2-receptor agonist, albuterol will be provided from screening to the
end of the treatment period for all subjects to use as needed to relieve COPD symptoms. At
the end of the treatment period, subjects can resume conventional therapy.
The study will randomize approximately 60 subjects. The total duration of subject
participation (from screening to follow-up) will be approximately 8 weeks.
n/a
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