This study will evaluate efficacy (FEV1), safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat inhaled doses of GW642444. This will be a multi-centre, double-blind, placebo controlled, dose ascending, four way cross-over study in approximately 28 mild to moderate asthmatic subjects. Key assessments: Efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics will be assessed by measurement of FEV1, blood pressure, heart rate, 12-lead ECGs, clinical laboratory tests, collection of adverse events (AE) information and blood samples.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
GSK Investigational Site
Wiesbaden, Hesse, Germany
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, Germany
GSK Investigational Site
Gothenburg, Sweden
FEV1 at 24 hours after a single dose.
Time frame: 24 hours on 4 separate occasions
FEV1 - Days 1 and 7
Time frame: Days 1 and 7 on 4 separate occasions
Mean morning/evening PEFR
Time frame: Days 3-8 on 4 separate occasions
BP, HR & QTc on Days 1 and 7
Time frame: Days 1 and 7 on 4 separate occasions
Potassium and glucose on Days 1 and 7
Time frame: Days 1 and 7 on 4 separate occasions
safety & tolerability as measured by AEs, laboratory safety tests, cardiac monitoring, VS & ECG
Time frame: throughout study
PK parameters
Time frame: Days 1, 4 and 7 on 4 separate occasions
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.