Long-term Safety Study for GSK573719/GW642444 in Japanese
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: GSK573719/GW642444 Inhalation Powder
Intervention description: GSK573719/GW642444 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); Pharmacogenetics; GSK573719/GW642444

Summary:

      The objective of this study is to evaluate the safety and tolerability of GSK573719/GW642444
      Inhalation Powder 125/25 mcg once-daily. The product will be delivered via the Novel Dry
      Powder Inhaler (nDPI) over 52 weeks to Japanese subjects with Chronic Obstructive Pulmonary
      Disease (COPD). This is a multi-centre, open-label study evaluating the safety of
      GSK573719/GW642444 Inhalation Powder 125/25 mcg. Treatment will be given once-daily in the
      morning. The target enrolment is approximately 120 subjects at approximately 20 study centres
      in Japan. The total duration of subject participation will be 54-55 weeks, consisting of a
      7-14 day run-in period, 52-week treatment period and 1-week follow-up period. Subjects
      meeting all of the inclusion criteria and none of the exclusion criteria at screening visit
      (Visit 1) will enter 7-14 day run-in period. The run-in period is provided for completion of
      baseline safety evaluations and to obtain baseline measures of COPD status. At Visit 2,
      eligible subjects will start to take GSK573719/GW642444 125/25 mcg, and enter the treatment
      period. This treatment will be delivered via the Novel Dry Powder Inhaler (nDPI) once daily
      in the morning for 52 weeks. One nDPI will contain 30 doses of study medication. Subjects
      will be instructed to administer medication once daily in the morning for the duration of the
      52-week treatment period. Each subject should be advised to adhere to this dosing regimen
      throughout the study. There will be a total of 8 study visits including at screening (Visit
      1), initiation of treatment (Visit 2), and at 4weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks,
      52 weeks (Visit 3 through Visit 8, respectively). Follow-up (Visit 9) will be conducted by
      the phone contact approximately 1 week following the completion/withdrawal of treatment
      period. A subject will be considered to have completed the study upon completion of the last
      on-treatment visit (Visit 8). At the end of the treatment period, subjects will be prescribed
      appropriate COPD medication at the investigator's discretion.
    

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 screening.

          -  Male or female subjects (female subjects who have child bearing potential has a
             negative pregnancy test at screening, and agrees to one of the acceptable
             contraceptive methods used consistently and correctly).

          -  Diagnosis of COPD.

          -  10 pack-year or greater history of cigarette smoking.

          -  Post-bronchodilator FEV1/FVC of <0.7.

          -  Predicted FEV1 of <80%.

        Exclusion Criteria:

          -  Women who are pregnant or lactating or are planning on becoming pregnant during the
             study.

          -  A current diagnosis of asthma.

          -  Respiratory disorders other than COPD.

          -  Clinically significant non-respiratory diseases or abnormalities that are not adequate
             controlled.

          -  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.

          -  A history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor
             antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical
             condition.

          -  Hospitalization for COPD or pneumonia within 12 weeks prior to screening.

          -  Subjects with lung volume reduction surgery within the 12 months prior to screening.

          -  Abnormal and clinically significant ECG findings at screening.

          -  Significantly abnormal finding from clinical chemistry or hematology, tests at
             screening.

          -  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 via nebulized therapy.

          -  Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks
             prior to screening.

          -  A know or suspected history of alcohol or drug abuse within 2 years prior to
             screening.

          -  Affiliation with the investigational site.

          -  Previous use of GSK573719, GW642444, the GSK573719/GW642444 combination or the
             Fluticasone Furoate/GW642444 combination.

          -  Use of any other investigational medication within 30 days or 5 drug half-lives
             (whichever is longer).