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

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Chronic Obstructive Pulmonary Disease (COPD), GSK573719, Pharmacogenetics Read More

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.