RecruitingPhase 4NCT05772013

Optimising Azithromycin Prevention Treatment in COPD to Reduce Exacerbations

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


Sponsor

Dr Ian B Wilkinson

Enrollment

1,311 participants

Start Date

Mar 5, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying the best way to use azithromycin — a low-dose antibiotic — to prevent flare-ups in people with chronic obstructive pulmonary disease (COPD). Some COPD patients are already prescribed azithromycin long-term to reduce these flare-ups (called exacerbations), and researchers want to find the optimal dosing schedule to make this treatment most effective. **You may be eligible if...** - You have a confirmed COPD diagnosis - You have been taking azithromycin as a preventive treatment for at least 3 months - You are 40 years or older - You have a smoking history of at least 10 pack-years - Your COPD is currently stable (no flare-up in the past 6 weeks) **You may NOT be eligible if...** - You are allergic to azithromycin or related drugs - You are pregnant, breastfeeding, or planning to become pregnant during the trial - You have certain other significant health conditions that make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzithromycin Pill

Participants will take azithromycin according to their standard of care prescription. If the participant is on the seasonal azithromycin treatment arm, they will only take azithromycin during the winter months (October-March) followed by matched placebo (April-September).

DRUGPlacebo

The placebo tablets will be matched in appearance, taste and smell to the azithromycin tablets.


Locations(1)

Cambridge University Hospital NHS Trust, Addenbrookes Hospital

Cambridge, United Kingdom

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NCT05772013


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