Dose-ranging study of the effects of SCH 527123 in subjects with COPD

• Research type

  Research Study

• Full title

  A dose-ranging study of the effects of SCH 527123 in subjects with moderate to severe COPD

• IRAS ID

  15459

• Contact name

  Neil C Thomson

• Sponsor organisation

  MSD

• Eudract number

  2008-003780-38

• ISRCTN Number

  n/a

• Research summary

  COPD is a chronic inflammatory lung disease in which airways become thick and inflamed, making it hard to breathe. 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 daily living activities. Neutrophils are thought to play an important role in the pathophysiology of COPD. It is theorized that reducing neutrophil migration to the diseased lung will improve a subject's symptoms and the natural history of the disease.This is an investigational clinical research study. The purpose of this study is to evaluate the safety and effectiveness of SCH 527123, a new investigational drug being studied, that may modify this inflammation and may eventually be used for the treatment of COPD. This is a double-blind, parallel arm, randomised study. 615 subjects (male and female, aged 40-75) were enrolled into the study. Subjects received either a low dose of SCH 527123, a medium dose of SCH 527123, a high dose of SCH 527123 or placebo.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  09/H0504/89

• Date of REC Opinion

  29 Sep 2009

• REC opinion

  Further Information Favourable Opinion