NCT05772013 Optimising Azithromycin Prevention Treatment in COPD to Reduce Exacerbations
| NCT ID | NCT05772013 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Dr Ian B Wilkinson |
| Condition | Chronic Obstructive Pulmonary Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,311 participants |
| Start Date | 2024-03-05 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,311 participants in total. It began in 2024-03-05 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
People living with chronic obstructive pulmonary disease (COPD) may experience worsening of symptoms such as shortness of breath, cough and wheezing in addition to changes that may be expected for having COPD. The worsening of symptoms is called exacerbations or flare-ups and can be debilitating and frightening, requiring additional treatment, often with azithromycin. This is an antibiotic medicine that also has anti-inflammatory properties. It is prescribed as long-term prevention to reduce the risk of flare-ups. Some people may be affected by side effects from azithromycin. Antibiotic resistance is another concern, especially when using azithromycin for prevention rather than to treat active infection. It is currently unclear as to whether people should be advised to stop taking azithromycin once COPD has stabilised, or to stop it over the summer when fewer flare-ups happen. It is also not known if azithromycin is more effective in some people or more likely to cause side effects in others. Given these uncertainties, it is challenging to know how best to use azithromycin in managing COPD. Azithromycin is a valuable antibiotic, and should be prescribed where it has benefit but avoid unnecessary side effects and reduce the chances of bacteria becoming resistant to it. The purpose of this trial is to be able to gain results to answer these questions, and to establish the effects of stopping azithromycin in people whose COPD has stabilised, who have been taking it for at least 3 months. This trial will compare continuing azithromycin with stopping it completely, or stopping over the summer only, continuing over the winter. The investigators will compare the effects of these three treatments in the trial on flare-ups, symptoms and quality of life, and find out what factors may affect how individual participants respond to them.
Eligibility 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.
Contact & Investigator
Ian B Wilkinson
STUDY DIRECTOR
University of Cambridge & University of Cambridge NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT05772013 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Chronic Obstructive Pulmonary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05772013 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05772013 currently recruiting?
Yes, NCT05772013 is actively recruiting participants. Contact the research team at zehra.yilmaz@nhs.net for enrollment information.
Where is the NCT05772013 trial being conducted?
This trial is being conducted at Cambridge, United Kingdom.
Who is sponsoring the NCT05772013 clinical trial?
NCT05772013 is sponsored by Dr Ian B Wilkinson. The principal investigator is Ian B Wilkinson at University of Cambridge & University of Cambridge NHS Foundation Trust. The trial plans to enroll 1,311 participants.