Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Randomized, Blinded, Double-dummy, Parallel-group Study to Evaluate the Efficacy and Safety of Umeclidinium (UMEC) 62.5 mcg Compared With Tiotropium 18 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
This is a multicentre, randomized, blinded, double dummy, parallel group study to evaluate
the efficacy and safety of UMEC inhalation powder[ (62.5 microgram (mcg) once daily (QD)]
when administered via a novel Dry Powder Inhaler compared with tiotropium (18 mcg QD)
administered via a HANDIHALER® inhaler over a treatment period of 12 weeks (24 weeks in
Germany) in subjects with chronic obstructive pulmonary disease (COPD). At the end of the
run-in period, subjects who meet the randomization criteria will be randomized to receive
UMEC 62.5 mcg administered via novel dry powder inhaler(nDPI) + Placebo administered via
HANDIHALER inhaler OR Tiotropium 18 mcg administered via HANDIHALER inhaler + Placebo
administered via nDPI in a 1:1 ratio. There will be up to 8 clinic visits conducted on an
outpatient basis at Pre-Screening (Visit 0), Screening (Visit 1), a 7 to 14 day run-in
period, 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). For subjects enrolled in
Germany, there will be an additional 3 visits at Day 112 (Visit 8), Day 140 (Visit 9) and Day
168 (Visit 10). The total duration of subject participation in the study will be
approximately 15 weeks (27 weeks in Germany). The primary endpoint of the study is clinic
visit trough forced expiratory volume in one second (FEV1) 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 blinded study medication at Visits
3 to 7.
HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG.
n/a
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