Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease (COPD), GSK573719, Pharmacogenetics
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 131
Healthy volunteers: no

Brief 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.

Detailed description:
Chronic Obstructive Pulmonary Disease (COPD) treatment guidelines recommend an incremental approach to pharmacological treatment as the disease state worsens, involving the use of combinations of drug classes with different or complementary mechanisms of action \[Celli, 2004, GOLD 2009\]. As disease progresses from mild to moderate, regular treatment with one or more long-acting bronchodilators is recommended. Inhaled bronchodilators, including beta2 agonists and anticholinergics are included with inhaled corticosteroids (ICS) therapy and are mainstays of therapy in patients diagnosed with COPD. Since GSK573719 Inhalation Powder is expected to be used for chronic management of COPD as long-acting muscarinic antagonist (LAMA), this study is intended to evaluate the safety and tolerability of long-term administration of GSK573719 Inhalation Powder 125 mcg in Japanese patients with COPD at doses possibly used to be in Japan.

In this study, patient safety will also be monitored by evaluating pulmonary function and clinical symptoms.

Arms:
arm 1: 125mcg

Interventions: intervention 1: GSK573719
Intervention descriptions: intervention 1: GSK573719 inhalation powder inhaled orally once daily for 52 weeks.

Protocol document: