RecruitingPHASE4INTERVENTIONAL

Chronic Airway Disease, Mucus Rheology and Exacerbations

This study is investigating a new way to use a medicine called azithromycin for people with Chronic Obstructive Pulmonary Disease (COPD). COPD can cause flare-ups, where breathing becomes much harder. We want to see if prescribing azithromycin based on how thick a person's mucus is, alongside their symptoms, helps reduce the number of flare-ups over a year. Currently, the medicine is usually given based on symptoms alone. By comparing these two approaches, we hope to find a better way to help people with COPD stay healthier and have fewer breathing crises, ultimately improving their quality of life.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

University Hospital, Montpellier

Enrolment target

Start

03 Feb 2023

Estimated completion

01 Feb 2026

Chronic Obstructive Pulmonary Disease

What is this study about?

This study is looking into a breathing condition called Chronic Obstructive Pulmonary Disease, or COPD. People with COPD often experience periods where their breathing suddenly gets much worse, known as 'flare-ups' or 'exacerbations'. These flare-ups can be very serious and sometimes require hospital stays.

The research focuses on a medicine called azithromycin. This antibiotic is sometimes used to help prevent these flare-ups. In this study, we're comparing two ways of deciding when to give azithromycin: one group will receive it based on their symptoms (like feeling more breathless or producing more phlegm), which is the usual way. The other group will receive it based on both their symptoms and a special test that measures how thick their mucus is.

Our main goal is to see if using this mucus thickness test, along with symptoms, can help people with COPD have fewer flare-ups over a year compared to just using symptoms. We'll also be looking at how people's symptoms change, their lung function, their overall health, and their quality of life throughout the study.

Key takeaways

This study is for people with COPD to help manage flare-ups.
It compares two ways of using the medicine azithromycin.
One way is based on symptoms, the other on symptoms and mucus thickness.
The goal is to reduce COPD flare-ups and improve quality of life.
Participants will be followed for a full year.
Your medical care is not affected if you choose not to participate.

Who may be eligible?

To join this study, you would generally need to be between 40 and 85 years old and have a diagnosis of COPD that has been confirmed for at least a year. You should also have experienced at least three COPD flare-ups in the past year, or at least one severe flare-up that needed hospital treatment. It's important that you are currently receiving the best possible treatment for your COPD, and you should be able to produce phlegm or mucus naturally, or when asked to.

There are also some health conditions or situations that would prevent you from taking part. For example, if you are pregnant or breastfeeding, or if you have certain severe heart, liver, or kidney problems. You also wouldn't be able to join if you've recently taken azithromycin, or if you are allergic to it or similar medicines. Safety is very important, so if certain other medications you take could interfere with azithromycin, or if you have specific lung diseases other than COPD, you wouldn't be able to participate.

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 between 40 and 85 years old?
Do you have confirmed COPD for at least one year?
Have you had at least 3 COPD flare-ups in the last year, or 1 severe flare-up requiring hospitalisation?
Can you reliably produce phlegm or mucus?
Are you able to attend appointments for a year?
Are you NOT pregnant or breastfeeding, and don't have certain serious heart, kidney, or liver conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be followed for 12 months. Throughout this time, you'll have regular check-ups, likely every three months, where the study team will monitor your symptoms, lung function, and how your mucus changes. You'll either receive azithromycin based on your symptoms or based on your symptoms and a mucus thickness test, depending on which group you are in. Researchers will also keep track of any other medications you take and any side effects you might experience. The total duration of your active involvement in the study, with all its procedures and follow-up, would be one year.

Potential risks and benefits

Participating in research studies like this can sometimes lead to potential benefits, such as receiving closer medical attention and potentially new insights into managing your COPD flare-ups. However, there are also potential risks; for example, azithromycin can have side effects, and some people may not respond to the treatment. There's also no guarantee that the new approach will be more effective than current care. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

University Hospitals of Bordeaux
Verified postcode
Bordeaux, France· Recruiting
University Hospitals of Montpellier
Verified postcode
Montpellier, France· Recruiting
University Hospitals of Toulouse
Verified postcode
Toulouse, France· Recruiting

Common questions

What is COPD?

COPD, or Chronic Obstructive Pulmonary Disease, is a long-term lung condition that makes it difficult to breathe. It can cause coughing, wheezing, and shortness of breath.

What are COPD flare-ups?

COPD flare-ups, also called exacerbations, are periods when your breathing symptoms suddenly become much worse. They can be serious and sometimes need hospital care.

What is azithromycin?

Azithromycin is an antibiotic medicine. In this study, we're looking at its potential to help prevent COPD flare-ups.

What does 'mucus rheology' mean in simple terms?

It's a scientific way of saying 'mucus thickness.' In this study, we're looking at how thick your mucus is, as well as your symptoms, to see if it helps decide when to use azithromycin.

Will I know which treatment group I'm in?

This information is usually shared by the research team. Sometimes in studies like this, you might not know, to ensure fair results.

How to find out more

Jérémy Charriot, MD

j-charriot@chu-montpellier.fr 04 67 33 67 33 Official trial record

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