A Dose-Ranging Study of the Effects of SCH 527123 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Schering-Plough
500 participants
Nov 11, 2009
Interventional
Conditions
Summary
Chronic Obstructive Pulmonary Disease (COPD) is a chronic inflammatory lung disease in which airways become thick and inflamed, making it hard to breathe. Cells in the airways make more mucus than usual, which tends to obstruct the airways, contributing to cough and difficulty getting air in and out of the lungs. Chronic inflammation present in COPD is a complex response of the immune system that may occur for a long period of time and cause undesirable consequences in the body tissues and organs. Inflammation may not only damage the lungs but also affect one’s daily living activities. Neutrophils are a type of white blood cells found in your lungs, that if increased, may cause lung damage. SCH 527123 is a new investigational drug that is intended to block the movement of neutrophils into the airways. Treatment with SCH 527123 may decrease the number of neutrophils in the airways which may lead to the improvement of lung function, COPD symptoms, COPD exacerbations and quality of life. Reducing the number of neutrophils in the airways may also prevent or delay the progression of disease as measured by the deterioration in lung function. The primary purpose of this study is to evaluate the safety and effectiveness of SCH 527123 in subjects with COPD.
Eligibility
Plain Language Summary
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Interventions
Arm 1: 10mgs SCH 527123 administered orally once daily for 26 weeks Arm 2: 30mgs SCH 527123 administered orally once daily for 26 weeks Arm 3: 50mgs SCH 527123 administered orally once daily for 26 weeks
Locations(1)
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ACTRN12610000345088