Long-term Safety Study for GSK573719 in Japanese
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: GSK573719
Intervention description: GSK573719 inhalation powder inhaled orally once daily for 52 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 131.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease (COPD), GSK573719, Pharmacogenetics

Summary:

      The objective of this study is to evaluate the safety and tolerability of GSK573719
      Inhalation Powder 125 mcg once-daily over 52 weeks in Japanese subjects with COPD.
    

Eligibility criteria:

        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.