Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Randomized, Open-Label, 8-Week Cross-Over Study to Compare Umeclidinium/Vilanterol With Tiotropium/Olodaterol Once-Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
The primary objective of this study is to assess the effect of umeclidinium/vilanterol
(UMEC/VI) versus tiotropium/olodaterol (TIO/OLO) in subjects with moderated COPD.
This is a multicentre, randomized, open label, 2 period crossover complete block design
study.
Eligible subjects, who complete a 2-week run-in period, will be randomized to receive a
sequence consisting of UMEC/VI inhalation powder (62.5/25 microgram [mcg] once-daily [QD])
administered as 1 inhalation via the ELLIPTA® Inhaler and TIO/OLO 5/5 mcg inhalation spray
administered as 2 inhalations via the RESPIMAT® inhaler, for 8 weeks each. This will be
followed by a 3-week washout period and one-week follow-up period. The total duration of
subject participation in the study will be approximately 22 weeks.
ELLIPTA is a registered trademark of the GlaxoSmithKline group of companies. RESPIMAT is a
registered trademark of Boehringer Ingelheim.
n/a
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