The purpose of this study is to assess the safety and efficacy of a single dosage strength of GW685698/GW642444 in subjects with Chronic Obstructive Pulmonary Disease (COPD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
GW685698/GW642444
GSK Investigational Site
Bergen, Norway
GSK Investigational Site
Elverum, Norway
GSK Investigational Site
Fredrikstad, Norway
GSK Investigational Site
Sandvika, Norway
Change From Baseline in Weighted Mean Heart Rate 0-4 Hours Post-dose at the End of the 28-day Treatment Period
Co-Primary Endpoint. Weighted mean was derived by calculating the average area under the curve (AUC), and then dividing by the relevant time interval. Baseline is the most recent result taken on or before pre-dose Day 1. Heart rate was recorded at 60 minutes (min) prior to dosing and at 15 min, 45 min, 90 min, 120 min, and 240 min post-dose on Day 28. Change from Baseline was calculated as the Day 28 value minus the Baseline value. Analysis was performed using a restricted maximum likelihood (REML)-based repeated measures mixed model approach (MMRM) with covariates of Baseline heart rate, sex, age, smoking status, treatment, and day and day by treatment and day by Baseline interactions. par.=participants.
Time frame: Baseline to Day 28
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Study
Co-Primary Endpoint. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. See the SAE/AE module of this results summary for a list of specific SAEs/AEs occurring in the study.
Time frame: From Baseline (Day 1) until Follow-up (up to Study Day 37)
Mean Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) on Days 2, 15, and 29
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Days 2, 15, and 29 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Days 1, 14, and 28. The highest of 3 technically acceptable measurements was recorded. Baseline FEV1 is defined as the mean of the two assessments obtained 30 minutes pre-dose and immediately pre-dose on Day 1. Change from Baseline was calculated as the Day 29 value minus the Baseline value. Analysis was performed using Mixed Model Repeated Measures (MMRM) with covariates of Baseline FEV1, sex, age, smoking status, treatment and day, and day by treatment and day by Baseline interactions.
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GSK Investigational Site
Trondheim, Norway
GSK Investigational Site
Gothenburg, Sweden
GSK Investigational Site
Luleå, Sweden
GSK Investigational Site
Lund, Sweden
GSK Investigational Site
Stockholm, Sweden
Time frame: Baseline; Day 2, Day 15, and Day 29
Mean Change From Baseline (Pre-dose on Day 1) in Weighted Mean FEV1 (0-4 Hours Post-dose) on Days 1 and 28
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Day 1 and Day 28 clinic visits (60 minutes pre-dose; immediately pre-dose; post-dose after 5, 15, and 30 minutes and 1, 2, and 4 hours. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the 0 to 4 hours post-dose assessment. At each time point, the highest of 3 technically acceptable measurements was recorded. Baseline FEV1 was defined as the mean of the two assessments obtained 30 minutes pre-dose and immediately pre-dose on Day 1. Change from Baseline was calculated as the average Day 28 FEV1 value minus the Baseline value. Analysis was performed using Mixed Model Repeated Measures (MMRM) with covariates of Baseline FEV1, sex, age, smoking status, treatment and day, and day by treatment and day by Baseline interactions.
Time frame: Baseline (pre-dose on Day 1); Day 1 and Day 28