Optimising azithromycin prevention treatment in COPD to reduce exacerbations (OPACE): A double blind adaptive design pragmatic phase IV randomised controlled trial

Research summary

Although patients with COPD at high risk of exacerbations are prescribed azithromycin to reduce their risk of exacerbations, we do not know what happens if azithromycin is discontinued when patients are stable, or whether certain subgroups of patients with COPD gain benefit from azithromycin prevention treatment whereas others may not. This is a double-blind, adaptive design pragmatic randomised controlled trial to assess the benefits and risks of azithromycin complete discontinuation versus continued use in COPD patients. We aim to identify subgroups of patients with COPD who respond well to azithromycin prevention treatment and those who do not. There are 2 arms to the trial: 1) Continued azithromycin prophylaxis (standard of care), 2) Complete discontinuation (matched placebo) It is an adaptive design trial, which allowed the seasonal arm of the trial to be stopped upon recommendations by the funder (NIHR HTA), and the relevant trial committees meetings in December 2024. This was just before the pilot phase of the trial was due to finish. Randomisation will be 1:1 to one of the 2 arms, via an online platform. Total number needed to recruit has reduced from 1311 to 618 following the discontinuation of the seasonal arm, in April 2025. It is a pragmatic trial, with home delivery of study medication. Up to 4 visits-can be in person or remote, over a median follow up of 20 months. The duration may be longer than 20 months depending on the time of participant recruitment to the trial. Visits can coincide with routine follow up to minimise the number of in-person visits.

Principal Investigator

Dr Rob Hallifax

Contact us

Email: samantha.chilcott@ndm.ox.ac.uk

IRAS number

1006202