None listed
Conditions
Brief 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.
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
Sponsors
Schering-Plough
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Has a diagnosis of clinically stable COPD (indicated by no exacerbations or changes in treatment within 6 weeks of screening. 2. Has a history for 3 months or more of sputum production most days of week. 3. Must be an ex-smoker with at least 6-months smoking cessation or a current smker with a smoking history of 10 or more pack-years.
Exclusion criteria
1. Has been diagnosed with asthma or other clinically relevant lung disease. 2. Has undergone a lobectomy, pneumonectomy, lung volume reduction or other lung surgery. 3. Needs supplemental oxygen therapy for more than 12 hours per day. 4. A low white cell count at the screening visit. 5. Subjects using medication that may interfere with the effect of the study medication or has a clinically relevant medical condition that interferes with study procedures/evaluations or any condition that is determined to be significant by the principal investigator.
Outcome results
None listed