Optimizing Azithromycin Use to Prevent COPD Exacerbations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.