Investigation Of A New Medication (GW642444) In Asthmatic Patients

A Multi-centre, Randomised, Double-blind, Placebo Controlled, Dose Ascending, Four Way Crossover Study to Examine Efficacy (FEV1), Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Doses of GW642444

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.

Inclusion criteria:

• Female subjects must be non-childbearing (i.e., surgically sterilised or post-menopausal).
• Non-smokers for at least 6 months.
• Stable asthma.

Exclusion criteria:

• Abnormal findings on heart monitoring assessment.
• Lower respiratory tract infection within 4 weeks, upper respiratory tract within 2 weeks of study.
• Currently taking doses of fluticasone propionate over 500mcg/day.
• Unstable asthma medication.