Repeat-Dose study of Intravenous GSK679586 in Severe Asthmatics, v1.0

• Research type

  Research Study

• Full title

  A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose study to evaluate the Efficacy and Safety of Intravenous GSK679586 in Patients with Severe Asthma

• IRAS ID

  11606

• Sponsor organisation

  GlaxoSmithKline UK Ltd

• Eudract number

  2008-004149-27

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The purpose of this study is to test the safety of GSK679586 and how well it works in patients with severe asthma. GSK679586 is currently not approved for doctors to prescribe to patients. GSK679586 is a new compound which is made of protein. GSK679586 is very similar in structure to certain proteins found in our bodies that are involved in natural defence mechanisms. However GSK678586 is very specific and is called a humanised monoclonal antibody. It attaches to another naturally occurring protein called Ó?Interleukin 13? or IL13. This study will compare GSK679586 and a placebo (dummy drug), which is an injection of saline (salt water) with no drug. One group of people will take GSK679586 and another group will take the placebo. The effects of the drug, both good and bad, will be compared to effects seen in people who are not taking the drug. The study doctor and the people who take part won??t know which group is getting which treatment. This way, the findings from the two groups will be handled in the same way.A computer will put people into groups by chance. Participants will have an equal chance of being placed in either group. Neither the participant nor the study doctor can choose a group. During the study, neither the participant nor the study doctor will know which group the participant's in. Information about how the study drug affects the participant's body and their health will be collected through a number of tests and procedures.This study will last about 47 weeks. During this time, participants will need to have tests, visit the clinic on schedule, and tell their study doctor about any changes.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  09/H0502/5

• Date of REC Opinion

  19 Feb 2009

• REC opinion

  Further Information Favourable Opinion