Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Study 201012: A Dose-Finding Study of Batefenterol (GSK961081) Via Dry Powder Inhaler in Patients With COPD
Batefenterol is a novel bifunctional molecule that combines muscarinic antagonism and
beta2-agonism in a single molecule. This is a multicenter, randomized, placebo-controlled,
double-blind, parallel group study primarily designed to assess the dose response, efficacy
and safety of five dose regimens of batefenterol administered via the dry powder inhaler
(DPI) once-daily in the morning for 42 days in subjects with COPD. The information obtained
from this study will be used to select the minimal, optimally effective and safe dose of
batefenterol and also to evaluate the pharmacokinetic profile and established pharmacodynamic
(PD) responses of batefenterol. These data will support for future studies with batefenterol
in COPD subjects.
The study will consist of a pre-screening visit, screening visit; a run-in period (2 weeks),
treatment period of 42 days and a follow-up visit 7 days post-treatment. The total duration
of the study for each subject will be approximately 9 weeks. Approximately 460 subjects will
be screened in order to randomize approximately 320 subjects, assuming that 280 subjects will
complete the study. During treatment period, subjects will be randomized to one of the
following treatments delivered via DPI once daily in the morning: Batefenterol 37.5 mcg, 75
mcg, 150 mcg, 300 mcg and 600 mcg, umeclidinium/vilanterol (UMEC/VI) 62.5/25 mcg and placebo.
All subjects will receive supplemental albuterol/salbutamol to be used on an as-needed basis
(rescue medication) throughout the study.
n/a
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