RecruitingPHASE4INTERVENTIONAL

Optimising Azithromycin Prevention Treatment in COPD to Reduce Exacerbations

This study, called "Optimising Azithromycin Prevention Treatment in COPD," aims to find the best way to use the antibiotic azithromycin for people with Chronic Obstructive Pulmonary Disease (COPD) to prevent flare-ups. Flare-ups are sudden worsenings of symptoms like breathlessness and cough. Azithromycin can help prevent these, but doctors aren't sure if it's best to take it long-term, stop it completely once COPD is stable, or only stop during summer. This research will compare these different approaches to see which one works best for reducing flare-ups, improving symptoms and quality of life, while also considering side effects and antibiotic resistance.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Dr Ian B Wilkinson

Enrolment target

1,311

Start

05 Mar 2024

Estimated completion

01 Nov 2028

Chronic Obstructive Pulmonary Disease

What is this study about?

If you live with COPD, you might experience "flare-ups" or "exacerbations." These are times when your breathing gets much worse, and you might cough, wheeze, or feel generally unwell. These flare-ups can be scary and often mean you need extra treatment.

One medicine often given to help prevent these flare-ups is called azithromycin. It's an antibiotic, but it also helps reduce inflammation in your lungs. While it's good at preventing flare-ups, doctors aren't completely sure about the best way to use it long-term. For example, should people keep taking it even if their COPD is stable? Is it okay to stop taking it during the summer when there are generally fewer flare-ups? There are also concerns about potential side effects and bacteria becoming resistant to the antibiotic.

This study aims to answer these important questions. It will compare three different methods for taking azithromycin: continuing it as usual, stopping it completely, or stopping it just for the summer months. By comparing these approaches, researchers hope to find out which one best helps people with COPD feel better, reduces flare-ups, and improves their quality of life, while also being mindful of side effects and reducing the risk of antibiotic resistance.

Key takeaways

This study evaluates different ways of taking azithromycin for COPD.
It compares continuing the medicine, stopping it completely, or stopping only in summer.
The goal is to reduce COPD flare-ups and improve quality of life.
It also considers side effects and antibiotic resistance.
You would be followed for about two years with regular check-ups.

Who may be eligible?

To join this study, you need to be an adult aged 40 or over who has a confirmed diagnosis of COPD. You should have been taking azithromycin to prevent flare-ups for at least three months, and your COPD should be stable, meaning you haven't had a flare-up in the last six weeks. You also need to have a history of smoking for at least 10 "pack years" (a way of measuring how much someone has smoked over time) and be willing to give your permission to take part.

However, this study might not be right for you if you are pregnant, planning to become pregnant, or currently breastfeeding. You also can't join if you have a known allergy to azithromycin or any of its ingredients, or if you have another serious medical condition that might make participating unsafe. If your doctor prescribed azithromycin for something other than COPD, or if you're already in another clinical trial for COPD, you won't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 40 years old or older?
Do you have a diagnosis of COPD?
Have you been taking azithromycin for COPD prevention for at least 3 months?
Have you not had a COPD flare-up in the last 6 weeks?
Are you not currently pregnant or planning to be?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of three groups. This means a computer will decide which group you are in, like flipping a coin, so it’s fair. You might continue taking azithromycin as usual, stop taking it completely (and take a dummy pill called a placebo instead), or take azithromycin in winter and a dummy pill in summer.

Neither you nor your study doctor will know which group you are in. You will be followed for about two years. During this time, you'll have regular check-ups, which might be at your GP practice, a community clinic, or a hospital. These check-ups will help the study team understand how you're feeling, new flare-ups, and your general health. You'll likely answer questionnaires about your symptoms and quality of life, but there will be no new specific tests like electrocardiograms (ECGs) required for the study.

Potential risks and benefits

Participating in this study could potentially help us understand the best way to manage COPD and reduce flare-ups, which could benefit you and many other people with COPD in the future. However, there are also potential risks; for example, stopping azithromycin might lead to more flare-ups for some individuals. There's also the chance of side effects from azithromycin if you continue taking it, or from not taking it. Please remember that you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Cambridge University Hospital NHS Trust, Addenbrookes Hospital
Verified postcode
Cambridge, United Kingdom· Recruiting

Common questions

What are COPD flare-ups?

COPD flare-ups are times when your breathing difficulties, cough, and other symptoms suddenly get much worse than usual, often requiring extra treatment.

What is azithromycin?

Azithromycin is a medicine that acts as an antibiotic, but it also has anti-inflammatory properties, meaning it can help reduce swelling and irritation in your lungs. It's used to prevent COPD flare-ups.

Why is this study needed?

Doctors aren't sure about the best way to use azithromycin long-term for COPD – whether to keep taking it, stop it, or take breaks. This study aims to find the safest and most effective approach.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the real medicine but contains no active drug. It helps researchers compare the effects of the actual medicine fairly.

Will I know which treatment I'm getting?

No, neither you nor your doctor will know which treatment group you are in. This helps ensure the study results are fair and unbiased.

How to find out more

Zehra T Yilmaz

zehra.yilmaz@nhs.net +44 (0)1223 256599 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.