Optimising Azithromycin Prevention Treatment in COPD to Reduce Exacerbations
Status:
Not yet recruiting
Trial end date:
2027-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Dr Ian B Wilkinson
Collaborators:
Eramol (UK) Ltd. Imperial College London Liverpool Heart and Chest Hospital NHS Foundation Trust Liverpool School of Tropical Medicine National Institute for Health Research, United Kingdom Newcastle University NHS Greater Glasgow and Clyde NHS Sunderland Clinical Commissioning Group Nottingham City Hospital Red Graphic Royal Brompton & Harefield NHS Foundation Trust Sealed Envelope Ltd. Swansea University University College London Hospitals University of Aberdeen University of Cambridge University of East Anglia WGK Clinical Services Ltd.