Study of GSK2862277 in Subjects Undergoing Oesophagectomy Surgery
Status:
Terminated
Trial end date:
2017-06-28
Target enrollment:
Participant gender:
Summary
Lung injury in patients undergoing oesophagectomy may occur during surgery (peri-operatively)
as a result of One Lung Ventilation (OLV) and/or during the immediate post-operative period
when patients receive intensive care. This is reinforced by the observation that
physiological markers of lung injury are most elevated immediately after completion of
surgery, and the development of clinical Acute Respiratory Distress Syndrome (ARDS)occurs
immediately post-operatively (within 72 hours of surgery), with the majority of cases
reported 24-48 hours after completion of surgery. This study is designed to investigate the
impact of pre-operative administration of GSK2862277 on biological and physiological markers
of lung injury in patients undergoing surgical resection of oesophageal cancer in order to
achieve optimal exposure at the site of injury following OLV and lung deflation. This study
is a randomized placebo controlled, double-blind, multi-centre, single dose parallel group,
design. There will be two treatment groups comprising one active and one placebo arm with
approximately 40 patients per group. Patients enrolled in the study will be scheduled to
undergo planned/elective trans-thoracic surgery for oesophagectomy. The primary endpoint for
this study is the change in pulmonary vascular permeability index (PVPI) from pre-surgical
levels to the end of surgery. GSK2862277 will be administered as an orally inhaled aerosol
(single nebulized dose) over approximately 3 to 5 minutes (min) 1-3 hours prior to surgery.
Subject will be monitored daily until discharge and followed up till day 28.