This is a randomised, double-blind, placebo-controlled, parallel group study to determine the efficacy of twenty-seven day- repeat inhaled daily doses of GW870086X on forced expiratory volume in 1 second (FEV1). Initially there will be 3 treatment arms; placebo, 2mg GW870086X and 4mg GW870086X. After an interim analysis the trial may; continue to completion using the original doses, be terminated early, or have a fourth arm added of either 1mg GW870086X once daily or 3mg GW870086X once daily.
This is a randomised, double-blind, placebo-controlled, parallel group study to determine the efficacy of twenty-seven day- repeat inhaled doses of GW870086X on FEV1. GW870086X is a novel inhaled corticosteroid with potent glucocorticoid activity currently in development by GlaxoSmithKline (GSK) as an inhaled treatment of persistent asthma. Initially, subjects will be randomised to receive placebo, 2mg or 4mg GW870086X once daily. An interim analysis will be performed on the primary endpoint to potentially adapt the study design after approximately 45 subjects have completed dosing. Based on the results of the interim analysis, the trial may continue to completion using the original doses or an adaptation to the doses could be made. Either the 1mg GW870086X once daily arm or 3mg GW870086X once daily arm may be added, or the trial could be terminated early. After screening there will be a 4 week run in period prior to start of treatment and after will be a follow up period 1-2 weeks after last dose. Approximately 120 subjects will complete the study. Key safety assessments include; clinical laboratory tests, vital signs and collection of adverse events (AE's).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
136
GSK Investigational Site
Sofia, Bulgaria
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, Germany
Change from baseline associated with GW870086X versus placebo at Day 28 on FEV1
Time frame: Day 28
Change from baseline in FEV1 on Day 7, Day 14 and Day 21
Time frame: Days; 7, 14, 21
Change from baseline in peak expiratory flow rate (PEFR) measured twice daily over 28 days
Time frame: Days 1-28
Rescue medication usage
Time frame: Days 1-28
Assessment of vital signs, safety laboratory parameters and incidences of adverse events throughout treatment period
Time frame: 9-10 weeks
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oral inhalation
oral inhalation
GSK Investigational Site
Hanover, Lower Saxony, Germany
GSK Investigational Site
Magdeburg, Saxony-Anhalt, Germany
GSK Investigational Site
Lübeck, Schleswig-Holstein, Germany
GSK Investigational Site
Berlin, State of Berlin, Germany
GSK Investigational Site
Berlin, State of Berlin, Germany
GSK Investigational Site
Bloemfontein, South Africa
GSK Investigational Site
George, South Africa
...and 1 more locations