RecruitingPhase 2ACTRN12610000345088

A Dose-Ranging Study of the Effects of SCH 527123 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)


Sponsor

Schering-Plough

Enrollment

500 participants

Start Date

Nov 11, 2009

Study Type

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

Sex: Both males and femalesMin Age: 40 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called SCH 527123 for people with moderate-to-severe COPD (chronic obstructive pulmonary disease). COPD is a serious lung disease that makes it progressively harder to breathe. The drug is designed to block certain white blood cells (neutrophils) from entering the airways, which may reduce inflammation, improve breathing, and reduce flare-ups. Researchers are looking for the right dose that works effectively and is safe. You may be eligible if: - You are between 40 and 75 years old - You have a stable COPD diagnosis (no flare-ups or treatment changes in the last 6 weeks) - You have had mucus production on most days for at least 3 months - You are either a current smoker with at least 10 pack-years of smoking history, or an ex-smoker who quit at least 6 months ago You may NOT be eligible if: - You have asthma or another lung disease - You have had lung surgery such as a lobectomy or lung volume reduction - You need supplemental oxygen for more than 12 hours per day - You have a low white blood cell count - You are taking medications that could interfere with the study drug Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

Australia

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