Reducing Neutrophils in Severe Asthma Treatment (RESET)

• Research type

  Research Study

• Full title

  Proof-of-Concept and Dose Range-Finding Study of SCH527123 in Subjects with Severe Asthma

• IRAS ID

  12284

• Contact name

  Christopher Brightling

• Sponsor organisation

  Schering Plough Research Institute

• Eudract number

  2008-004119-36

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The purpose of this study is to evaluate the safety and Effectiveness of the study drug SCH 527123, compared with placebo, in reducing severe asthma exacerbations (worsening) in subjects with severe asthma. SCH 527123 is a new investigational drug being studied in this clinical trial. SCH 527123 is intended to block the migration of neutrophils into the airways. It is thought that the neutrophils, a type of white blood cell, cause inflammation in your lungs. The study is also designed to help define the optimal dose for the study drug. The study is a randomised, double-blind, placebo-controlled, multicenter study. The study will be conducted at approximately 140 centers in multiple countries including Canada, Europe, and South America. Approximately 500 subjects (male and female, ages 18-70) will participate in this study. There will be approximately 5 subjects enrolled at each study site. The study subjects will be required to come to the clinic 13 times over a period of about 29 weeks, during which their condition will be carefully monitored.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  09/H0406/122

• Date of REC Opinion

  4 Feb 2010

• REC opinion

  Further Information Favourable Opinion