Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Randomized, Double Blind, Placebo Controlled, Incomplete Block, Crossover, Dose Ranging Study to Evaluate the Dose Response of GSK573719 Administered Once or Twice Daily Over 7 Days in Patients With Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to further characterize the dose response of GSK573719 at doses of 15.6 micrograms (mcg) to 125 mcg once daily in patients with chronic obstructive pulmonary disease (COPD). Treatment with doses of GSK573719 dosed twice daily will also be included to further evaluate dosing frequency. Treatment with tiotropium (18 mcg) once daily via the Handihaler will be included as an active control. A placebo treatment will be included in order to evaluate absolute treatment effect of the different doses of GSK573719.
Inhaled bronchodilators, such as beta 2 agonists and anticholinergics, and inhaled
corticosteroids are the mainstays of therapy in patients diagnosed with COPD. Anticholinergic
bronchodilators or long acting muscarinic receptor antagonists function by blocking
endogenous airway smooth muscle cholinergic tone. Treatment with anticholinergics has been
shown to significantly improve forced expiratory volume in 1 second (FEV1), resting and
dynamic lung hyperinflation, symptoms, and exercise capacity in patients with COPD. Currently
tiotropium is the only approved long acting muscarinic antagonist available for treatment of
COPD.
This is a multicenter, randomized, double-blind, placebo controlled, three way crossover,
incomplete block study to evaluate 4 doses of GSK573719 inhaled once daily and 2 doses of
GSK573719 inhaled twice daily over 7 days in patients with COPD. Tiotropium will be included
as an open label active comparator. A placebo treatment will be included to evaluate
treatment effect of each GSK573719 dose. Pharmacokinetic profiles of GSK573719 will also be
determined. Each eligible subject will receive a sequence of 3 of 8 potential treatments for
a total of 3 treatment periods per subject. There will be 7 clinic visits, during three of
which 24 hour serial spirometry will be performed. The total duration of subject
participation is approximately 9 weeks.
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