AuthorisedTherapeutic use (Phase IV)Interventional

The impact of extra-fine inhalation corticosteroid particles on small-airway disease in Chronic Obstructive Pulmonary Disease (COPD): a randomized, prospective cross-over trial.

This study is being done to understand if a special kind of inhaler, which delivers very fine medicine particles, can help people with Chronic Obstructive Pulmonary Disease (COPD). COPD affects your breathing and can make your airways narrower. We know that some inhalers deliver medicine that might not reach the very smallest breathing tubes in the lungs. This trial aims to find out if using an inhaler that creates extra-fine particles of a common COPD medicine (a corticosteroid) can get deeper into the lungs. By reaching these smaller airways, the researchers hope to see if it can improve how people with COPD breathe and feel. It’s a follow-up study, meaning the medicine is already used for other things, but we're learning more about how it works for COPD in a specific way.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

CHU Saint Pierre

Enrolment target

Start

19 Jan 2026

Chronic Obstructive Pulmonary Disease

What is this study about?

Imagine your lungs are like a tree, with bigger branches leading to smaller twigs. In COPD, the small twigs (your small airways) can get blocked or inflamed, making it harder to breathe. We have medicines that help open up the airways and reduce inflammation, often given through inhalers.

This study is looking at a type of inhaler that produces incredibly tiny particles of medicine. Think of it like a very fine mist. The idea is that these super-small particles might be able to travel deeper into your lungs and reach those smaller airways that are often affected by COPD. If the medicine can get to where it's needed most, it might work better to relieve symptoms and help you breathe more easily.

The main goal is to compare how well these extra-fine particles work compared to other forms of the same medicine. It's about finding the best way to deliver treatment to help people with COPD feel better and manage their condition more effectively.

Key takeaways

Looks at how very tiny medicine particles in an inhaler might help COPD.
Aims to improve breathing by reaching smaller airways in the lungs.
Compares different ways of delivering the same COPD medicine.
For adults aged 18 years and over with COPD.
Involves using different inhalers and attending regular check-ups.
You can stop participating at any time.

Who may be eligible?

To join this study, you would need to be an adult, 18 years old or older. There is no upper age limit, meaning older adults are welcome to participate too. Both men and women are invited to take part.

You would also need to have a confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD). The research team will check other health details to make sure the study is a safe and good fit for you. They will explain everything clearly before you decide to join.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with Chronic Obstructive Pulmonary Disease (COPD)?
Are you able to attend appointments at a study clinic?
Are you willing to try different inhaler medications as part of the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would be asked to attend several visits to the study clinic. During these visits, the research team would carry out different assessments, such as breathing tests (like spirometry) to measure your lung function and perhaps ask you questions about your symptoms and how you are feeling. You would be given study medication, an inhaler, to use as instructed. This study uses a "cross-over" design, which means you'll try one type of treatment for a period, then switch to another, and the researchers will compare the effects. You would also have regular follow-up appointments to monitor your health and how you're responding to the treatment. The total duration of your participation in the study would be explained to you in detail.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. The potential benefits of this study include receiving specialist care, close monitoring of your COPD, and possibly improving your breathing or symptoms. However, there's no guarantee the treatment will work for you, and there might be side effects from the medication, even though it's already a commonly used type. The study team will explain all known side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Belgium

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a common lung disease that makes it hard to breathe. It includes conditions like emphysema and chronic bronchitis.

What is an inhaler?

An inhaler is a device that helps deliver medicine directly into your lungs. You breathe in the medicine through a mouthpiece.

What does 'extra-fine particles' mean?

It means the medicine in the inhaler is broken down into very, very tiny pieces, much smaller than in some other inhalers, so it can travel deeper into your lungs.

Is this a new medicine?

No, the medicine itself (a corticosteroid) is already approved and used. This study is looking at a new way of delivering it, with extra-fine particles, to see if it works better for COPD.

What does a 'cross-over trial' mean?

It means you will use one type of inhaler for a period, then switch to another type for another period. This allows researchers to compare the medicines within the same person.