COPD-ST2OP: A randomised placebo-controlled trial of anti-ST2 in COPD
Chief Investigator: Professor Chris Brightling
Study start date: October 2018
COPD, or chronic obstructive pulmonary disease, is a significant cause of illness and death worldwide. It is associated with sudden worsening of symptoms that can lead to hospitalisation, such as shortness of breath and a chesty cough with phlegm that never seems to go away. We do not fully understand the cause of COPD but if we can find out, it will help to design the best treatment for the disease.
An exciting new trial called COPD-ST2OP is comparing Anti-ST2, an experimental and currently unlicensed drug, with a placebo (‘dummy drug’) to treat COPD with the aim of reducing the number of flare ups of symptoms.
Participants will receive the treatment by infusion under the skin once every four weeks for 48 weeks. They will also undergo a series of tests and assessments (e.g. spirometry, sputum, nasal and breath samples and a CT scan of the chest) to assist the research team to understand how the treatment affects their health status, respiratory symptoms, lung function and airway inflammation. Participants will be evaluated for an additional 12 weeks following completion of the randomised treatment period.
The main aim of the trial is to evaluate whether Anti-ST2 will impact on airway inflammation in COPD and therefore reduce the frequency of exacerbations (i.e. flare-ups of symptoms). For the purposes of this trial, exacerbations are defined as flare-ups of symptoms involving the use of healthcare resulting in treatment with steroids and/or antibiotics and/or hospitalisation or death due to COPD.
The trial is taking place within our respiratory facility at Glenfield Hospital, led by Professor Chris Brightling. The trial is sponsored by the University of Leicester and funded by Genentech, a biotechnology company based in San Francisco, California.
This study is now closed to recruitment.
For more information, please contact the local research nurses on the details below;
Sarah Parker: firstname.lastname@example.org / 0116 258 3277
Joanne Finch: email@example.com / 0116 258 3072
The trial manager is Niamh Quann COPD-ST2OP@leicester.ac.uk / 0116 2297243