Optimising Azithromycin Prevention Treatment in COPD to Reduce Exacerbations (OPACE): A Double Blind Adaptive Design Pragmatic Phase IV Randomised Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
Cambridge University Hospital NHS Trust, Addenbrookes Hospital
RECRUITING
Cambridge
Contact Information
Primary
Zehra T Yilmaz
zehra.yilmaz@nhs.net
+44 (0)1223 256599
Backup
Heike Templin
heike.templin@nhs.net
+44 (01223 250874
Time Frame
Start Date: 2024-03-05
Estimated Completion Date: 2028-11
Participants
Target number of participants: 1311
Treatments
Active_comparator: Continuous azithromycin
Participants in this arm will continue with their standard of care (i.e. continuous dose of azithromycin according to their standard prescription) throughout the trial.
Other: Seasonal azithromycin
Azithromycin will be taken by participants during the autumn-winter (October - March).~Matched placebo will be taken by the participants in the spring-summer (April - September).
Placebo_comparator: Complete Discontinuation of azithromycin
Participants will take continuous matched placebo throughout the trial.
Sponsors
Leads: Dr Ian B Wilkinson
Collaborators: University of Cambridge, University of Aberdeen, Newcastle University, Royal Brompton & Harefield NHS Foundation Trust, Liverpool Heart and Chest Hospital NHS Foundation Trust, NHS Greater Glasgow and Clyde, WGK Clinical Services Ltd., Sealed Envelope Ltd., Red Graphic, Liverpool School of Tropical Medicine, NHS Sunderland Clinical Commissioning Group, National Institute for Health Research, United Kingdom, Eramol (UK) Ltd., Imperial College London, University of East Anglia, Nottingham City Hospital, University College London Hospitals, Swansea University

This content was sourced from clinicaltrials.gov