A 4-week Dose-Ranging, Dose-Interval, Efficacy, Safety and Tolerability Study of GSK961081 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Exclusion Criteria

• •Women who are pregnant or lactating or are planning to become pregnant during the study.
• •Current diagnosis of asthma
• •Other significant respiratory disorders besides COPD, including alpha-1 deficiency
• •Previous lung resection surgery
• •Significant abnormalities in chest x-ray presentation
• •Hospitalization for a COPD exacerbation within 12 weeks prior screening
• •Use of oral corticosteroids or antibiotics for COPD or antibiotics for a lower respiratory tract infection within 6 weeks
• •Any significant disease that would put subject at risk through study participation
• •BMI greater than 35
• •Pacemaker
• •Significantly abnormal ECG, clinical lab finding (including Hepatitis B or C)
• •Cancer
• •Allergy or hypersensitivity to beta adrenergic receptor-agonist, sympathomimetic, anticholinergic/anti-muscarinic receptor antagonist, or inhaler excipients
• •Diseases that would contra-indicate the use of anticholinergics
• •Use of sysemic corticosteroids within 6 weeks of screening
• •Use of long-acting beta-agonists within 48 hours of screening
• •Use of tiotropium within 7 days of screening
• •Use of theophyllines or anti-leukotrienes within 48 hours of screening
• •Use of short-acting bronchodilators within 4 hours of screening
• •Use of investigational medicines within 30 days of screening
• •Use of high dose inhaled corticosteroids
• •Use of long-term oxygen therapy, CPAP or NIPPV
• •Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1
• •Regular (q.i.d or greater) use of short acting bronchodilators, including nebulized therapy
• •Affiliation with Investigator Site
• •Questionable Validity of Consent
• •Previous use of GSK961081