Repeat Doses Of A New Medication (GW642444) In Asthmatic Patients

Multi-centre, Randomised, Double-blind, Placebo-controlled, Four-way Incomplete Block Crossover Study, to Examine Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Administration of Three Inhaled Doses (25, 100 and 400 mcg Once Daily) of GW642444

In order to obtain information on a wider range of doses of GW642444 (a possible new medication to treat asthma) than has been previously examined in asthmatic patients, this current study will be conducted at doses of 25 100 and 400 mcg of GW642444 and will be compared with salmeterol (50 mcg twice daily). This study will be conducted in a similar manner to a study that has already been completed (study number B2C101762) which examined repeat doses of 50, 100 and 200 mcg of GW642444. The data obtained will compliment the data from study B2C101762 and will provide confidence (or not) that the desired bronchodilation can be achieved and maintained without undesirable side effects.

Inclusion criteria:

• Subjects with a documented history of persistent asthma.
• Current non-smokers.
• Clinically stable persistent asthma FEV1 between 60 and 90% of predicted values.
• Inhaled corticosteroid therapy at a total daily dose between 200-500mcg of fluticasone or equivalent.

Exclusion criteria:

• Subjects with significant past or present disease which which may affect their safety.
• Upper or lower respiratory tract infection within 4 weeks of screening.
• History of life threatening asthma, or asthma requiring treatment with oral corticosteroids within 3 months of study.
• Patients taking doses of inhaled corticosteroid >500mcg/day and patients who have changed therapy within 8 weeks of the study.
• Patients weighing less than 50kg.