Long-term Safety Study for GSK573719 in Japanese (AC4115361)

Inclusion Criteria:

• Outpatient.
• A signed and dated written informed consent prior to study participation.
• Japanese subjects 40 years of age or older at Visit 1.
• Male or female subjects. A female is eligible if she is of: Non-child bearing potential or Child bearing potential agrees to one of the contraceptive methods.
• Subjects with a clinical history of COPD in accordance with the definition by COPD domestic guideline.
• Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at Visit 1.
• Subject with a measured post-salbutamol forced expiratory volume/forced vital capacity (FEV1/FVC) ratio of <70% and Subjects with a measured post-salbutamol FEV1 <80% of predicted normal values.

Exclusion Criteria (Visit 1):

• Women who are pregnant or lactating or are planning on becoming pregnant during the study.
• A current diagnosis of asthma.
• Known respiratory disorders other than COPD.
• Subjects with historical or current evidence of clinically significant abnormalities that are uncontrolled.
• A chest X-ray or computed tomography (CT) scan that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD.
• Allergy or hypersensitivity to muscarinic, beta2-agonist, lactose/milk protein or magnesium stearate or a condition that contraindicates participation.
• Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.
• Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1).
• An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1.
• Significantly abnormal finding from clinical chemistry or hematology, tests at Visit 1.
• Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day.
• Regular use (prescribed every day, not for as-needed use) of short-acting bronchodilators (e.g., salbutamol) via nebulized therapy.
• Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1.
• A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1.
• Affiliation with Investigator Site.
• Previous use of GSK573719, the GSK573719/GW642444 combination.
• Use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer).

Exclusion Criteria (Visit 2):

- COPD Exacerbation during run-in period: Subject must not have experienced a COPD exacerbation or a lower respiratory tract infection during run-in or at Visit 2.