Long-term Safety Study for GSK573719 in Japanese

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

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.