This study is primarily designed to assess the dose response, dose interval, efficacy and safety of three once daily (QD) doses (100mcg, 400mcg and 800mcg) and three twice daily (BID) doses (100mcg, 200mcg and 400mcg,) of GSK961081 administered via DISKUS™ for 28 days in subjects with moderate/severe COPD versus placebo. Salmeterol 50mcg BID is included in the study as an active comparator.
This is a phase IIb multicentre, randomised, double-blind, double-dummy, placebo- and active-controlled, parallel-group, dose-ranging and dose-interval study. Eligible subjects will enter a seven-day run-in period followed by 28 days of double-blind, double-dummy treatment via the DISKUS inhaler. The study will consist of 8 visits, mainly conducted on an outpatient basis, 6 of which will be clinic visits and 2 of which will be phone contacts, including a post-treatment visit to follow up any adverse events. There will be approximately 425 subjects randomised to the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
437
Comparison of different doses and dosing regimens of the drug
Positive control
Placebo arm
Change in FEV1 from baseline in pre-dose AM trough.
Pre-dose change in AM FEV1 on day 29 vs baseline . (defined as the mean values recorded 11 and 12 hours after the PM dose on day 28)
Time frame: 28 Day
Weighted Mean and Serial FEV1 at multiple timepoints
In the subset of patients with overnight spirometry on day 28 (pre-dose and post dose after 15,30, and 60 min and 2, 4,6, 11 and 12 hours)
Time frame: 28 Days
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GSK Investigational Site
Tallinn, Estonia
GSK Investigational Site
Tallinn, Estonia
GSK Investigational Site
Tallinn, Estonia
GSK Investigational Site
Tartu, Estonia
GSK Investigational Site
Frankfurt am Main, Hesse, Germany
GSK Investigational Site
Gelnhausen, Hesse, Germany
GSK Investigational Site
Dresden, Saxony, Germany
GSK Investigational Site
Lübeck, Schleswig-Holstein, Germany
GSK Investigational Site
Berlin, State of Berlin, Germany
GSK Investigational Site
Berlin, State of Berlin, Germany
...and 39 more locations