Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Multicenter, Trial Comparing the Efficacy and Safety of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily With Tiotropium 18 mcg Once Daily Over 24 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this 24 week study is to evaluate the spirometric lung function effect (trough FEV1) of Umeclidinium/Vilanterol 62.5/25 once daily compared to Tiotropium 18 mcg once daily along with safety assessments in subjects with COPD.
This is a Phase IIIb multicenter, randomized, double-dummy, parallel group study to evaluate
the efficacy and safety of UMEC/VI Inhalation Powder (62.5/25 mcg) when administered
once-daily via a novel dry powder inhaler (DPI) compared with tiotropium (18 mcg)
administered once-daily via the HandiHaler over a treatment period of 24 weeks in subjects
with COPD. Eligible subjects will be randomized 1:1 to UMEC/VI Inhalation Powder (62.5/25
mcg), or tiotropium (18 mcg) for 24 weeks.
There will be a total of 10 study clinic visits conducted on an outpatient basis. Subjects
who meet the eligibility criteria at Screening (Visit 1) will complete a 7- to 10-day run-in
period followed by a 24-week treatment period. Clinic visits will be at Screening,
Randomization (Day 1), Day 2 and after 4, 8, 12, 16, 20 and 24 weeks, and 1 day after the
Week 24 visit (Visit 1 to Visit 10, respectively). Additionally a safety Follow-Up assessment
will be conducted either by phone call or clinic visit where required approximately 7 days
after the end of the study treatment (Visit 10 or Early Withdrawal, if applicable). The total
duration of subject participation, including the Follow-Up will be approximately 26 weeks.
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