Acute Lung Injury Trial

• Research type

  Research Study

• Full title

  A Placebo Controlled, Double-blind, Multi-centre, Repeat Dose, Parallel Group, Randomised Clinical Trial of GSK2862277 in Patients undergoing Oesophagectomy Surgery.

• IRAS ID

  158411

• Contact name

  Gavin Perkins

• Contact email

  g.d.perkins@warwick.ac.uk

• Eudract number

  2014-000643-33

• Research summary

  Sometimes following surgery for oesophageal cancer, the lungs become inflamed and breathing becomes difficult this is called acute respiratory distress syndrome (ARDS). The causes are not yet fully understood, but may be as a result of the operation. The condition causes severe breathlessness and patients may have to stay longer in intensive care.
  This study will test whether GSK2862277 (the study drug) can prevent any of the bad effects that sometimes happen in the lungs during and perhaps after the oesophagectomy operation. This drug might help patients with ARDS or perhaps prevent ARDS in the future.
  GSK2862277 is a fully-human domain antibody. Monoclonal antibodies are proteins which are found in blood and tissue. They are able to recognise and stick to other proteins (known as ‘antigens’) and stop them from working.
  The study consists of a screening, treatment and a follow-up phase. It is expected to last about 6 weeks.
  Patients will take a single dose of study treatment before the operation. Treatment could be GSK2862277 or placebo (dummy- no actual drug) and this is decided randomly by a computer. Patients have a half/half chance of receiving either treatment. The study treatment will be given by an inhalation over 3-5 minutes . During surgery, any changes in the lungs will be assessed and a sample of fluid will be taken from the lungs to examine in the laboratory.
  Other tests include
  • Physical examination & medical history, heart monitoring
  • Various blood tests
  • Pharmacokinetic blood tests (to measure the amount of study drug in the blood)
  • Vital signs: weight, height, blood pressure and pulse

  Patients will be asked to give a blood sample 1 week before the operation, to test for antibodies they have to the drug. If antibodies are found, those patients will not be able to take part in the study as this may prevent the medicine from working.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  14/WM/1050

• Date of REC Opinion

  26 Aug 2014

• REC opinion

  Further Information Favourable Opinion