Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Randomized, Parallel-group, Open-label Study to Evaluate the Efficacy and Safety of Umeclidinium (UMEC) 62.5 mcg Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
This is a 12-week, multicentre, randomized, open-label, 2-arm, parallel-group study designed
to compare the efficacy and safety of umeclidinium inhalation powder (62.5 mcg once daily
[QD]) administered via a novel Dry Powder Inhaler (nDPI) with glycopyrronium (44 mcg QD)
administered via a Breezhaler® inhaler in subjects with COPD over 12 weeks of treatment. At
the end of the run-in period, eligible subjects will be randomized in a 1:1 ratio to receive
umeclidinium 62.5 mcg administered via nDPI or glycopyrronium 44 mcg administered via
BREEZHALER inhaler. There will be up to 8 clinic visits conducted on an outpatient basis at
Pre-Screening (Visit 0), Screening (Visit 1), Randomization at Day 1 (Visit 2), and after
Randomization at Day 2 (Visit 3), Day 28 (Visit 4), Day 56 (Visit 5), Day 84 (Visit 6) and
Day 85 (Visit 7). The total duration of subject participation in the study will be
approximately 15 weeks. The primary endpoint of the study is clinic visit trough FEV1 (forced
expiratory volume in one second) on treatment Day 85. All subjects will have spirometry
performed at clinic Visits 1 though 7. Trough spirometry will be obtained 23 and 24 hours
after the previous day's dose of open-label study medication at Visits 3 to 7.
BREEZHALER is a registered trademark of Novartis AG.
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