RecruitingPhase IVInterventional

Optimising the use of azithromycin antibiotic to reduce Bronchiectasis flare-ups

If you have bronchiectasis, you might take an antibiotic called azithromycin to help stop flare-ups, which are sudden worsenings of your symptoms. This study wants to find out if it's safe and effective for people to stop taking azithromycin once their bronchiectasis has become stable for a while. Some people worry about side effects from azithromycin or about antibiotics becoming less effective over time. This research will compare what happens to people who continue taking azithromycin versus those who stop it. We'll look at how many flare-ups they have, their symptoms, and their overall well-being. The aim is to help doctors understand the best way to use azithromycin for people with bronchiectasis in the long run.

At a glance

Status

Recruiting

Phase

Phase IV

Sponsor

Newcastle upon Tyne Hospitals NHS Foundation Trust

Enrolment target

1,000

Start

01 Jul 2025

Estimated completion

31 Dec 2026

Medical condition: Bronchiectasis Medical condition in lay language: Bronchiectasis Therapeutic areas: Diseases [C] - Respiratory Tract Diseases [C08]

What is this study about?

This study is for people living with bronchiectasis, a long-term lung condition. Sometimes, bronchiectasis can cause 'flare-ups' where symptoms like coughing, shortness of breath, or wheezing get much worse. Doctors often prescribe an antibiotic called azithromycin to help prevent these flare-ups from happening. This medicine can also help calm inflammation in the lungs.

While azithromycin can be very helpful, doctors aren't sure if people need to keep taking it forever, especially if their bronchiectasis has been stable for a long time. There are also concerns about potential side effects from long-term use and the risk of bacteria becoming resistant to antibiotics over time. This trial aims to answer a really important question: what happens if someone who has been taking azithromycin for a while and whose condition is stable decides to stop taking it?

The main goal of this study is to see if stopping azithromycin is a good option for some people. We will compare two groups: one that continues to take azithromycin and another that stops. By doing this, we hope to learn if people can maintain their stable condition without the medication, and whether it affects their flare-ups, symptoms, and how they feel day-to-day. This information will help doctors decide the best way to use azithromycin for people with bronchiectasis in the future.

Key takeaways

This study is exploring if some people with stable bronchiectasis can safely stop taking azithromycin.
It aims to find the best long-term way to use azithromycin for bronchiectasis, balancing benefits and risks.
Participants will either continue azithromycin or switch to a dummy pill for 12 months.
Your health will be closely monitored by a dedicated study team throughout the trial.
The findings will help improve future treatment decisions for people with bronchiectasis in the UK.
You can leave the study at any time without it affecting your usual care.

Who may be eligible?

To join this study, you need to be at least 16 years old and have a clear diagnosis of bronchiectasis. Your bronchiectasis should be stable, meaning you haven't had a flare-up requiring antibiotics for at least 30 days before joining.

You must also have been taking azithromycin (or a similar long-term antibiotic from the 'macrolide' family) regularly for at least 90 days (about three months) within the last year, specifically to help prevent flare-ups. A past CT scan confirming your bronchiectasis is also needed.

There are some reasons you couldn't take part. These include being pregnant, planning to become pregnant, or breastfeeding. Also, if you have any other serious health conditions that your doctor thinks would make it unsafe for you to either continue or stop taking azithromycin for this study, you wouldn't be able to join.

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 16 years old or older?
Do you have a confirmed diagnosis of bronchiectasis?
Has your bronchiectasis been stable (no flare-ups needing antibiotics) for at least 30 days?
Have you been taking azithromycin (or a similar antibiotic) for at least 3 months in the last year to prevent flare-ups?
Are you NOT currently pregnant, planning pregnancy, or breastfeeding?
Are you willing and able to understand and sign a consent form?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll either continue taking azithromycin in the same way you usually do, or you'll switch to a dummy pill (placebo) for 12 months. You won't know which one you're taking, and neither will your study doctor. The dose of medication will be the same as what you're currently prescribed, whether that's three times a week or every day. You'll take the medicine by mouth.

Throughout the 12 months, the study team will keep in close contact with you. This will likely involve regular phone calls or visits to check on how you're feeling, monitor your symptoms, and make sure you're taking your medication correctly. They'll also ask about any flare-ups you might have and how they affect your daily life. They'll ensure you don't run out of your study medication.

The study will last for 12 months in total, during which your health and well-being related to your bronchiectasis will be carefully followed. If your regular hospital appointments can't be used for study check-ups, some study visits might take place remotely by phone or video call to make it easier for you.

Potential risks and benefits

You might not personally benefit directly from taking part in this study, but your health will be closely monitored, and you'll have extra contact with healthcare professionals. If you are in the group that stops azithromycin, you might experience fewer side effects that are related to the antibiotic. The information we gather will be incredibly valuable for future patients with bronchiectasis, helping doctors understand the best and safest ways to use azithromycin long-term. There is a chance you might experience more bronchiectasis flare-ups if you stop taking azithromycin, or you might still have side effects if you continue taking it. The study team will watch you very closely for any of these issues. If you have three or more flare-ups within the year, the study doctor will review whether you should stop the trial medication and restart your usual azithromycin. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (26)

Freeman Hospital [Lead site]
City only
Newcastle upon Tyne, England
Royal Brompton & Harefield Hospital
City only
London, England
North Tyneside General Hospital
Approximate
North Shields, England
Royal Papworth Hospital
Approximate
Cambridge, England
Southampton General Hospital
Approximate
Southampton, England
Bradford Royal Infirmary
Unverified
Bradford, England
Addenbrookes Hospital
Unverified
Cambridge, England
Torbay Hospital
Unverified
Torquay, England
Greater Lancashire Hospitals
Unverified
Preston, England
Westmorland General Hospital
Unverified
Kendal, England
Bristol Royal Infirmary
Unverified
Bristol, England
Wythenshawe Hospital
Unverified
Manchester, England

Common questions

What is a 'flare-up' of bronchiectasis?

A flare-up, also called an exacerbation, is when your bronchiectasis symptoms like coughing or breathlessness suddenly get worse than usual and need treatment, often with antibiotics.

What is azithromycin?

Azithromycin is an antibiotic. For people with bronchiectasis, it's often prescribed not just to fight infections, but also to help reduce inflammation and prevent flare-ups.

Will I know if I'm taking the real medicine or a dummy pill?

No, neither you nor your study doctor will know if you're taking azithromycin or a dummy pill (placebo). This helps make sure the study results are fair and accurate.

How long will I be in the study?

You will be in the study for 12 months, during which your health will be carefully monitored.

What happens if my bronchiectasis gets worse during the study?

Your health will be closely watched. If you experience several flare-ups, the study doctor will decide if you should stop the study medication and go back to your usual treatment.

How to find out more

Anthony De Soyza

anthony.de-soyza@newcastle.ac.uk +44 (0)191 2231439 Official trial record

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