OPACE
Research type
Research Study
Full title
Optimising azithromycin prevention treatment in COPD to reduce exacerbations (OPACE): A double blind adaptive design pragmatic phase IV randomised controlled trial
IRAS ID
1006202
Contact name
Ian Wilkinson
Contact email
Sponsor organisation
Cambridge University Hospital NHS Foundation Trust and University of Cambridge
Research summary
People living with chronic obstructive pulmonary disease (COPD) may experience worsening of symptoms such as shortness of breath, cough and wheezing in addition to changes that may be expected for having COPD. The worsening of symptoms is called exacerbations or flare-ups and can be debilitating and frightening, requiring additional treatment, often with azithromycin. This is an antibiotic medicine that also has anti-inflammatory properties. It is prescribed as long-term prevention to reduce the risk of flare-ups. Some people may be affected by side effects from azithromycin. Antibiotic resistance is another concern, especially when using azithromycin for prevention rather than to treat active infection. We currently don’t know whether to advise people to stop taking azithromycin once COPD has stabilised or stop it over the summer when fewer flare-ups happen. We also don’t know if azithromycin is more effective in some people or more likely to cause side effects in others. Given these uncertainties, it is challenging to know how best to use azithromycin in managing COPD. Azithromycin is a valuable antibiotic, and we want to prescribe it where it has benefit but we want to avoid unnecessary side effects and reduce the chances of bacteria becoming resistant to it. The purpose of this trial is to be able to gain results to answer these questions. We want to establish the effects of stopping azithromycin in people whose COPD has stabilised, who have been taking it for at least 3 months. In this trial, we will compare continuing azithromycin, with stopping it completely, or stopping over the summer only, continuing over the winter. We will compare the effects of these three treatments in the trial on flare-ups, symptoms and quality of life and also find out what factors may affect how individual participants respond to them.
REC name
London - Central Research Ethics Committee
REC reference
23/LO/0167
Date of REC Opinion
26 Sep 2023
REC opinion
Further Information Favourable Opinion