Unlike many other diseases, the prevalence of COPD is not declining. Data from a 2022 Asthma and Lung UK report showed that there are approximately 1.4 million people diagnosed with COPD, which is around 2% of the whole population of the UK. Respiratory research is a vital part of improving patient care overall, but this is particularly the case where the burden of disease has such a significant impact. To address this, it is necessary that research is undertaken to determine the best ways to improve clinical practice and therefore patient outcomes.
Dr Marie Fisk, Respiratory and Acute Medicine Consultant at Cambridge University Hospitals NHS Foundation Trust & University of Cambridge, shared an update into a recent National Institute for Health and Care Research (NIHR) study that aims to grow evidence for use of azithromycin in prevention of exacerbations in COPD.
What is the OPACE trial?
The OPACE trial is a NIHR study that aims to find out how best to use azithromycin in COPD. Currently, there is a lot of uncertainty and a lack of evidence to guide clinical practice.
The trial is in patients with COPD who are on azithromycin and will compare continuing azithromycin, vs a trial of stopping it completely, or stopping it seasonally (that is stopping it over the summer and being on azithromycin over the winter).
The trial is assessing exacerbations and will follow up participants about their COPD and general health. It is a pragmatic trial, and participants can take part from home if easier for them and there is home delivery of trial medication. It is also planned to collect routine data on hospital admissions during the trial. Participants also will stop trial medication if required to restart their usual azithromycin but will still be followed up in the study.
What were the drivers behind focusing on this particular area of clinical practice?
Currently, there is a lot of uncertainty in how to optimally use azithromycin in COPD. We are lacking the evidence to know what happens when azithromycin is stopped, or used seasonally, or continued to be used for more than 1 year. Although we often employ these interventions in clinical practice, we don’t have the evidence to guide what we do. We also don’t know which patients are more likely to gain benefits from azithromycin or not or may be at higher risk of harm. All medications have potential benefits and side effects. Azithromycin use can rarely affect the heart and hearing and there is concern about antibiotic resistance.
We want to make sure we are using azithromycin, a valuable antibiotic appropriately for individual patients.
What are the goals of the OPACE trial?
- To gain good quality evidence on how best to use azithromycin in COPD for our patients, to guide future optimal prescribing and de-prescribing of it, where appropriate.
- To be an accessible research study to take part in, given that participants can take part from home.
- To be a collaborative research study that encourages collaboration across primary and secondary care across the UK.
How can health professionals/clinics become involved in the trial? Where can people learn more?
Please contact the OPACE team. We are actively looking for potential sites and healthcare professionals that are interested in joining our research collaboration. There are lots of opportunities to be involved, such as being a full research site or participant identification site. There are training opportunities too; OPACE is part of the NIHR Associate Principal Investigator scheme and there are also training webinars and learning events too.