RecruitingPHASE1, PHASE2INTERVENTIONAL

Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness

This research study is investigating a new inhaler called Trixeo Aerosphere for people living with Chronic Obstructive Pulmonary Disease (COPD). The main goal is to understand exactly how this medicine works to improve breathing patterns and reduce feelings of breathlessness. Researchers are looking at its effect on lung function and how easily people can breathe. This is an early-stage study, meaning it's one of the first times scientists are closely examining the drug's effects in people. It will involve participants using the inhaler while doctors monitor their breathing and overall lung health. The study hopes to provide valuable information about how this treatment can help those with COPD.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

University Hospital, Lille

Enrolment target

Start

29 Sep 2023

Estimated completion

01 Sep 2026

Copd

What is this study about?

This study is about a medicine called Trixeo Aerosphere, which is an inhaler. It's designed to help people who have Chronic Obstructive Pulmonary Disease, or COPD for short. COPD makes it hard to breathe, often causing shortness of breath. The main aim of this research is to understand *how* this specific inhaler works in the body to improve breathing and reduce that feeling of breathlessness.

Think of it like this: your lungs have tiny airways, and with COPD, these airways can become narrower, making it harder for air to get in and out. This inhaler contains different medicines that are thought to help open up these airways and make breathing easier. Researchers want to observe closely what changes happen in your breathing patterns and lung function when you use Trixeo Aerosphere. This will help them learn more about its benefits.

This is an early step in understanding new medical treatments. By carefully studying how this inhaler affects breathing and lung health, doctors hope to gather important information that could improve how COPD is managed in the future. The results from studies like this are crucial for developing better ways to help people with breathing conditions.

Key takeaways

This study is for people with COPD.
It investigates an inhaler called Trixeo Aerosphere.
The main goal is to understand how the inhaler improves breathing.
Participation involves using the inhaler and regular health checks.
It's an early-stage study to learn more about the medicine's effects.
You can leave the study at any time.

Who may be eligible?

To join this study, you generally need to be between 40 and 75 years old and have a clear diagnosis of COPD. You should also have a history of smoking for at least 10 years, even if you've stopped, and experience noticeable shortness of breath, rated as moderate or worse.

However, there are reasons you might **not** be able to join. For example, if you also have asthma or a mix of asthma and COPD, or if you've had a recent chest infection or a flare-up of your COPD in the last couple of months. Serious heart problems, like a recent heart attack or certain types of irregular heartbeats, would also prevent you from participating.

They will also check for other significant health issues, such as severe kidney or liver problems, certain eye conditions like narrow-angle glaucoma, or if you have very high blood pressure that isn't under control. The study team will review all your health information carefully to make sure it's safe for you 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 between 40 and 75 years old?
Do you have a diagnosis of COPD?
Do you experience significant shortness of breath, often rated as moderate or worse?
Have you smoked for more than 10 years in your life?
Do you *not* have asthma or the asthma-COPD overlap syndrome?
Have you been free of a chest infection or serious COPD flare-up in the last 6-8 weeks?

Answer every question to see your result.

What does participation involve?

If you join this study, you would first need to sign a consent form, which explains everything in detail. You would then be given the Trixeo Aerosphere inhaler to use. Throughout the study, doctors and nurses will regularly check your breathing, lung function, and how you feel. This might involve breathing tests, blood tests, and possibly heart scans (ECGs). The study is planned to monitor how your breathing changes over time with the new inhaler.

Potential risks and benefits

Taking part in any study has potential benefits and potential risks. You might benefit from closer medical attention and potentially from the study medicine itself, though this is not guaranteed as treatments work differently for everyone. Risks could include side effects from the medication or discomfort from tests. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

CHU de Lille
Verified postcode
Lille, France· Recruiting

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease, a lung condition that makes it hard to breathe.

What is Trixeo Aerosphere?

It's an inhaler medicine being studied to see how it helps people with COPD breathe better.

Is this a new medicine?

It's a medicine that's already used, but this study is looking deeper into *how* it works in the body.

Will I get 'fake' medicine?

No, this study is 'single-arm,' meaning everyone who takes part will receive the Trixeo Aerosphere inhaler.

How long will the study last?

The information provided doesn't specify the exact duration, but clinical studies can vary in length.

How to find out more

Thierry PEREZ, MD

thierry.perez@chu-lille.fr 0320445962 Official trial record

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