University of CambridgeCambridge University HospitalsNational Institute for Health Research

OPACE: Optimising Azithromycin prevention treatment in COPD to reduce Exacerbations

The OPACE trial aims to find out how best to use azithromycin in chronic obstructive pulmonary disease (COPD).

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Long-term azithromycin treatment may have benefits but also risks; such as antibiotic resistance and it may be less effective in some patients compared to others. It is therefore important to have evidence to guide the best ways to use azithromycin as a prophylactic (i.e. protective) agent for patients with COPD.

The OPACE trial will compare the continuous use of Azithromycin by COPD patients with either seasonal or more permanent cessation use of the antibiotic. The OPACE trial is funded by the Health Technology Assessment (HTA) Programme, National Institute of Health and Care Research (NIHR) and we are looking to recruit patients with COPD across the UK. We are particularly keen to recruit participants from areas with high levels of COPD and from areas that are less research-active.

If you suffer from COPD and would like to volunteer to be a participant on the trial, please read below to find out more about the trial.

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For Potential Participants

We encourage you to consider participating in this trial if:

  • You suffer from chronic obstructive pulmonary disease (also known as COPD) and
  • You have been on the antibiotic Azithromycin for at least 3 months.

We are looking for volunteers to join this trial from across the UK.

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For Healthcare Professionals

We encourage participation in this trial from primary and secondary care sites across the UK, especially from areas with high chronic obstructive pulmonary disease (COPD) prevalence.

If you work in GP practices or secondary care sites (including participant identification centres – PICs), please click below to find out more about the trial and how to become a trial site.

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Explore OPACE

The OPACE trial is for people with chronic obstructive pulmonary disease (COPD) who are more in stable in their COPD and have been taking azithromycin long-term to reduce experiences of flare-ups (also known as exacerbations of COPD symptoms that may result in hospitalisation).

OPACE is designed to determine whether stopping azithromycin either completely or seasonally over the summer is no worse than continuing it.

Participants enrolled in the OPACE trial will be randomly allocated to one of three interventions which will be provided as trial medication:

  • Continuous Azithromycin as usual
  • Seasonal discontinuation – Azithromycin during the autumn-winter; placebo ‘dummy azithromycin’ during the spring-summer
  • Complete discontinuation – continuous Placebo ‘dummy azithromycin’

During the OPACE trial, neither the participant nor the trial team will know which intervention (trial arm) the participant is allocated to. This will help to avoid any bias in the data collected.

Trial medication is delivered to participants’ homes. Trial medication can be stopped if needed and participants restart their usual azithromycin if advised to. All participants will still be followed up in the trial.

Depending on the results obtained during the trial, we may decide to withdraw one of the trial arms if necessary.

Participants are monitored during the trial with a combination of face-to-face appointments and telephone follow up. Face to face appointments can be conducted by telephone (or video if facilities available) if preferred.

Target recruitment is at least 1311 participants involving GP practices and hospitals across the UK.

Trial News
All approvals received for OPACE trial!

  As of 26th Sep 2023, we are pleased to confirm final approvals have been received from the Medicines and Healthcare products Regulatory Agency (MHRA), the Research Ethics Committee (REC), and Health Research Authority (HRA) for the OPACE trial to proceed. What happens next? Following approvals, we can start initiating and activating sites to begin […]

Read More… from All approvals received for OPACE trial!

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