The purpose of this study is the evaluate the safety and tolerability of repeat dosing of the combination of inhaled GSK233705 and GW642444 administered once-daily in subjects with COPD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
61
matching placebo
The combination of the long-acting muscarinic antagonist GSK233705 and the long acting beta agonist GW642444 in a single inhaler.
GSK Investigational Site
Mobile, Alabama, United States
GSK Investigational Site
Wheat Ridge, Colorado, United States
GSK Investigational Site
Biddeford, Maine, United States
Change From Baseline in Weighted Mean Pulse Rate Over (0-4 Hours) at Day 28.
Baseline was the most recent result taken on or before pre-dose (Day 1). The analysis was performed using a Repeated Measures Model. This model used all available weighted mean pulse rate values recorded. Change from Baseline was calculated as (Change from Baseline = Assessment value - Baseline value).
Time frame: Baseline (Pre-dose, Day 1) and Day 28
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Time frame: On-treatment; from treatment start until one day after treatment stop (Up to Day 29)
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GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
Summit, New Jersey, United States
GSK Investigational Site
Medford, Oregon, United States
GSK Investigational Site
Erie, Pennsylvania, United States
GSK Investigational Site
Greenville, South Carolina, United States
GSK Investigational Site
Spartanburg, South Carolina, United States
GSK Investigational Site
Johnson City, Tennessee, United States
...and 2 more locations