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NCT05772013 · ClinicalTrials.gov record · last posted 2024-04-03

Optimising Azithromycin Prevention Treatment in COPD to Reduce Exacerbations

Study acronym: OPACE
StatusRecruiting
PhasePhase 4
Started2024-03-05
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from the ClinicalTrials.gov record
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.

Amendment record 1 amendment on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended once since 2023-03-15. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2024-04-02
Status change Not Yet RecruitingRecruitingv1
Trial Details
NCT Number NCT05772013
Lead Sponsor Dr Ian B Wilkinson
Collaborators: University of Aberdeen, NHS Greater Glasgow and Clyde, University of East Anglia, Nottingham City Hospital, Swansea University, Newcastle University, University of Cambridge, NHS Sunderland Clinical Commissioning Group, Liverpool School of Tropical Medicine, Royal Brompton & Harefield NHS Foundation Trust, University College London Hospitals, Liverpool Heart and Chest Hospital NHS Foundation Trust, Imperial College London, Red Graphic, Eramol (UK) Ltd., WGK Clinical Services Ltd., Sealed Envelope Ltd., National Institute for Health Research, United Kingdom
Conditions Chronic Obstructive Pulmonary Disease
Enrollment 1,311 participants
Start Date 2024-03-05
Primary Completion 2028-06 (estimated)
Study Completion 2028-11 (estimated)
Updated on ClinicalTrials.gov 2024-04-03