Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A 52-week, Multi-centre, Open-label Study to Evaluate the Safety and Tolerability of GSK573719 125 mcg Once-daily Via Novel Dry Powder Inhaler (nDPI) in Japanese Subjects With Chronic Obstructive Pulmonary Disease.
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.
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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