Neutrophils distribution in lungs in health and COPD
Research type
Research Study
Full title
Measurement of neutrophil retention in the lung in vivo, using autologous radio-labelled neutrophils, in healthy subjects following lipopolysaccharide or saline challenge and patients with Chronic Obstructive Pulmonary Disease (COPD).
IRAS ID
166387
Contact name
Edwin Chilvers
Contact email
Duration of Study in the UK
1 years, 4 months, 9 days
Research summary
GlaxoSmithKline is exploring a new technique to examine how neutrophils behave in the lungs of healthy volunteers compared to patients with chronic obstructive pulmonary disease (COPD). Neutrophils (white blood cells) are believed to play a central role in the development of COPD.
There are few accurate and reproducible techniques to measure the medical signs (biomarkers) of this disease in the whole lung. Neutrophils from healthy volunteers and COPD patients, tagged with radioactivity, are re-injected into a vein in their arm. The measurement and behaviour of neutrophils will be assessed when participants undergo a special imaging technique called a SPECT CT scan.
There are 2 groups in this study. In group 1, 22 healthy volunteers will complete assessments in one visit. After predose assessments, they are randomly selected to receive an inhalation of saline (salty water) or LPS solution (Lipopolysaccharide). The tagged neutrophils are re-injected followed by imaging and blood sampling at a number of timepoints over 6 hours. A follow up phone call will be made approximately 24hrs post inhalation and a follow up visit 5 -14 days later. In group 2, 24 stable COPD patients will complete assessments in visit 1. Ten patients will return to complete identical assessments in visit 2, 7-10 days later. Assessments are the same as in Group 1 except there is no inhalation challenge in Group 2.
Taking part in the study will not have direct benefit to participants. All participants will be admitted to a specialist clinical research unit with adequate safety and compliance facilities for conducting this research.
Results from this study will support the design of future studies in diseases where neutrophils are believed to play a role in their pathology.
The study is sponsored by GlaxoSmithKline in collaboration with University of Cambridge and Cambridge University Hospitals NHS Foundation Trust.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
14/EE/1273
Date of REC Opinion
23 Feb 2015
REC opinion
Further Information Favourable Opinion