A 52-Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Tolerability of GSK573719/GW642444 and GSK573719 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this 52-week study is to evaluate the long-term safety (in terms of adverse
      events, COPD exacerbations, laboratory, ECG, and Holter findings, vital signs, use of rescue
      medication and lung function) of GSK573719/GW642444 Inhalation Powder 125/25mcg in subjects
      with COPD. The long-term safety of GSK573719 Inhalation Powder 125mcg will also be evaluated.
      A placebo arm is included to evaluate these products compared to an inactive control.
    

Detailed description: 
      Several studies have demonstrated the efficacy and safety of combining an individual LABA
      compound plus an individual LAMA compound in COPD. These studies have shown the combination
      of these two products to be superior to either agent alone on a variety of outcomes in COPD.
      The beneficial effects of this combination regimen are likely due to the different mechanisms
      of action of the two bronchodilators (smooth bronchial muscle relaxation from activation of
      beta2 receptors from the LABA product and inhibition of acetylcholine-mediated smooth
      bronchial muscle contraction via blockade of muscarinic receptors from the LAMA product). The
      availability of a LABA/LAMA combination in one product instead of two individual products is
      a technical and therapeutic advancement in the pharmacological armamentarium for COPD and may
      lead to increased patient compliance due to once-daily administration. The purpose of this
      52-week study is to evaluate the long-term safety (in terms of adverse events, COPD
      exacerbations, laboratory, ECG, and Holter findings, vital signs, use of rescue medication,
      and lung function) of GSK573719/GW642444 Inhalation Powder 125/25mcg in subjects with COPD.
      The long-term safety of GSK573719 Inhalation Powder 125mcg will also be evaluated. A placebo
      arm is included to evaluate these products compared to an inactive control. All treatments
      will be delivered once-daily via the nDPI. This study will establish the long-term safety
      profile of GSK573719/GW642444 Inhalation Powder 125/25mcg once-daily in subjects with COPD.
      The safety profile of GSK573719 Inhalation Powder125mcg once-daily will also be evaluated.
    

Intervention name(s): 125/25 mcg once-daily GSK573719/GW642444; 125mcg once-daily GSK573719; Placebo once-daily
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK573719/GW642444; GSK573719; inactive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Chronic Obstructive Pulmonary Disease; COPD; nDPI; long-acting beta agonist; long-acting muscarinic antagonist; tolerability; safety