Optimizing Azithromycin Use to Prevent COPD Exacerbations
Optimising Azithromycin Prevention Treatment in COPD to Reduce Exacerbations (OPACE): A Double Blind Adaptive Design Pragmatic Phase IV Randomised Controlled Trial
This study is testing whether stopping azithromycin treatment helps people with stable COPD avoid flare-ups while also looking at safety and side effects.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1311 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust Academic / other |
| Locations | 1 site (Cambridge) |
| Trial ID | NCT05772013 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of discontinuing azithromycin treatment in patients with stable chronic obstructive pulmonary disease (COPD) who are at high risk for exacerbations. Participants will be randomly assigned to one of three groups: complete discontinuation, seasonal discontinuation, or continued treatment with azithromycin. The study aims to determine the best approach to managing azithromycin therapy to minimize exacerbations while considering potential side effects and antibiotic resistance. The trial will utilize a double-blinded, adaptive design to ensure robust results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 and older with a clinical diagnosis of COPD who have been on prophylactic azithromycin for at least three months and are clinically stable.
Not a fit: Patients who are currently pregnant, breastfeeding, or have a known hypersensitivity to azithromycin will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help optimize treatment strategies for COPD patients, potentially reducing the frequency of exacerbations and improving quality of life.
How similar studies have performed: Previous studies have shown varying results regarding the use of azithromycin in COPD management, making this approach both relevant and necessary to explore further.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be able and willing to provide informed consent. * Have an established clinical diagnosis of COPD and be receiving prophylactic azithromycin for ≥ (at least) 3 months to reduce COPD exacerbations. * Have a self-reported smoking history of ≥ (at least) 10 pack years. * Be aged \>= 40 years. * Have clinically stable COPD, i.e. no COPD exacerbation for at least 6 weeks. Exclusion Criteria: * Known hypersensitivity to any of the trial drugs or excipients. * Current breast feeding, pregnancy or planned pregnancy during the trial. * Any medical history or clinically relevant abnormality that makes participant ineligible for inclusion because of a safety concern relating to continuing or discontinuing azithromycin or other considerations. * Known immunodeficiency requiring immunoglobulin/specific antibody therapy. * Azithromycin prophylaxis prescribed for non-COPD condition. * Active participation in COPD Clinical Trial of an Investigational Medicinal Product (CTIMP). Electrocardiograms (ECGs) will not be a trial assessment nor entry requirement.
Where this trial is running
Cambridge
- Cambridge University Hospital NHS Trust, Addenbrookes Hospital — Cambridge, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Zehra T Yilmaz
- Email: zehra.yilmaz@nhs.net
- Phone: +44 (0)1223 256599
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.