Phase IIb Study of Umeclidinium (UMEC) Bromide Versus Placebo in Subjects With Asthma
Status:
Completed
Trial end date:
2018-05-30
Target enrollment:
Participant gender:
Summary
This study is conducted to evaluate the effects of UMEC 62.5 microgram (mcg) and UMEC 31.25
mcg on lung function versus placebo after 24 weeks of treatment. This study will provide
important information regarding the efficacy and safety of UMEC when administered in a
separate inhaler to subjects on a background of fluticasone furoate (FF). This is a Phase
IIb, randomized, double-blind, placebo controlled study that will compare the efficacy,
safety and tolerability of UMEC (62.5 mcg and 31.25 mcg) administered once-daily in subjects
with asthma that is not well controlled. Eligible subjects will be requested to participate
in the study for a maximum of approximately 31 weeks with 4 phases (pre screening,
screening/run-in, randomization/treatment and safety follow-up). The total number of
randomized subjects required is approximately 384, with 128 subjects randomized 1:1:1 to each
of the 3 double-blind treatment arms.