About OPACE:
In chronic obstructive pulmonary disease (COPD), azithromycin is often used as a prophylactic treatment rather than to treat active infection. We want to prescribe azithromycin where it has benefit, but avoid unnecessary side effects and reduce the chances of bacteria becoming resistant to it. Currently, there is no evidence to know what happens when azithromycin is stopped either completely, or stopped temporarily over the summer in people with COPD.
This trial aims to establish the effects of stopping azithromycin prevention in people whose COPD is more stable, who have been taking azithromycin for at least 3 months.
We will compare i) continuous azithromycin, with stopping it ii) completely, or iii) stopping over the summer only and continuing azithromycin over the winter. We will compare effects of these three trial arms on flare-ups, symptoms and quality of life and also find out what factors may affect how individual participants respond.
Patients with clinically stable chronic obstructive pulmonary disease (COPD; i.e. whom hasn’t had a COPD flare-up for at least 6 weeks before time of enrolment) can be screened for eligibility for the trial.
The key steps within the OPACE trial will include the following:
Background to the trial:
Prophylactic azithromycin is recommended as a treatment to reduce the risk of COPD exacerbations in people with COPD at high risk of exacerbations. In clinical practice, there is much uncertainty in how to optimally use this valuable antibiotic in managing COPD.
It is unknown whether azithromycin is effective beyond one-year of treatment; what happens when azithromycin is discontinued following a period of use; or temporarily discontinued over the summer when there are fewer exacerbations. Although we do undertake these interventions in clinical practice; we currently have no evidence about their effects. We also don’t know if there are differences in treatment responsiveness to azithromycin between subgroups of people with COPD.
Aim of the trial:
To evaluate the benefits and risks of complete or seasonal discontinuation of azithromycin chemoprophylaxis vs continued treatment in people with stable COPD on long-term azithromycin.
Trial design:
OPACE is a randomised double-blinded, non-inferiority, adaptive-design pragmatic trial of 3 parallel arms:
· complete discontinuation of prophylactic azithromycin
· seasonal discontinuation (discontinue over the summer, active over the winter)
· continued azithromycin prophylaxis as standard of care
Trial population:
This trial will be in COPD patients on azithromycin prevention to reduce their risk of COPD exacerbations. Patients will need to be on azithromycin for at least 3 months and to be exacerbation-free for at least 6 weeks before enrolment in the study.
Setting:
GP practices, specialist community clinics, hospitals.
What is involved for patients and research sites:
Patients:
Patients will be followed up in the study for a median of 24 months. The trial can be conducted at home remotely, or patients can come in for visits, depending on their preference.
Trial medication will be delivered to patients’ homes from a central pharmacy to avoid need of visits for trial medication.
Outcome measures:
Sample size:
We need to randomise 1311 patients (437 per arm)
If, having read the trial information you would like your site to participate in the trial, please complete the “Expression of Interest Form” below.
We will then get in touch with you with the outcome.
GP practices, hospitals and Participant Identification Centres (PICs) are welcome to apply.
Please contact us if you have any questions at: [email protected]
If your site is suitable for activation for the trial, you will be granted access to the Secure Area below. The secure area will provide access to materials to help your site become activated for OPACE, as well as other key trial documents and training.
Please follow this link if you would also like to participate within the Associate Principal Investigator Scheme.
Welcome to the first OPACE newsletter! Many thanks to you all for your hard work and support in this trial. SITES UPDATE We currently have 12 research sites active for OPACE, which include: Primary Care Sites Secondary Care Sites · Heath Lane Surgery · Vauxhall Primary Health Care · Knutsford Medical Partnership · […]
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 […]