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)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): GSK573719; GSK573719; GSK573719; GSK573719; GSK573719; GSK573719; Tiotropium; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 125 mcg once daily; 62.5 mcg once daily; 31.25 mcg once daily; 15.6 mcg once daily; 31.25 mcg twice daily; 15.6 mcg twice daily; 18 mcg once daily; once or twice daily
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Long acting muscarinic antagonist; Tiotropium; Chronic Bronchitis; Emphysema; Chronic Obstructive Pulmonary Disease