Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Randomised, Placebo-Controlled, Double-Blind, Multi-Centre, 4-week, 3-way Crossover Pharmacodynamic Study to Assess the Equivalence of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO Compared with BGF Delivered by MDI HFA in Participants with Chronic Obstructive Pulmonary Disease

This research is looking at an inhaler used to treat moderate to severe Chronic Obstructive Pulmonary Disease (COPD). The study compares two slightly different versions of the same inhaler, called Trixeo Aerosphere. One uses a new propellant (HFO) and the other uses the existing one (HFA). We want to find out if the new version works just as well as the current one in helping people with COPD breathe better. The study also checks if both versions of the Trixeo inhaler are more effective than a dummy inhaler (placebo). We'll be measuring how well people's lungs work, specifically looking at how much air they can breathe out.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Astrazeneca AB

Enrolment target

Start

25 Mar 2024

Moderate to Severe Chronic Obstructive Pulmonary Disease(COPD)

What is this study about?

This study is all about helping people with a lung condition called Chronic Obstructive Pulmonary Disease, or COPD. If you have moderate to severe COPD, your airways can become inflamed and narrowed, making it hard to breathe. Inhalers are often used to deliver medicines that help open up these airways and make breathing easier.

The main goal of this particular study is to compare two slightly different versions of an inhaler called Trixeo Aerosphere. Think of it like comparing two cars of the same model, but one has a slightly different engine or fuel type. One version uses a standard propellant (the stuff that helps spray the medicine out) and the other uses a newer, potentially more environmentally friendly one. We want to see if this new version works just as effectively as the current one in improving your breathing.

To make sure we get clear results, the study also includes a 'dummy' inhaler, called a placebo. This helps us ensure that any improvements we see are truly because of the Trixeo medicine and not just because people expect to feel better. By doing this comparison, researchers can confirm if the new inhaler is a safe and effective option for treating COPD.

Key takeaways

Tests two versions of a COPD inhaler (Trixeo Aerosphere).
Compares them to each other and to a dummy inhaler.
Aims to see if a new inhaler version works just as well.
Participants will have their breathing closely monitored.
The study lasts about four weeks.
For adults aged 18 and over with moderate to severe COPD.

Who may be eligible?

To join this study, you need to be at least 18 years old – there's no upper age limit. Both men and women can take part.

Crucially, you must have been diagnosed with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). The research team will have specific medical criteria to decide if your COPD symptoms and lung function measurements fit what they're looking for.

There might be other health conditions or medicines that would prevent you from joining, as the study needs to ensure it's safe for participants and that results are clear. The study team will review all your medical information carefully to see if you are a good fit.

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 18 years old or older?
Have you been diagnosed with moderate to severe COPD?
Are you able to attend regular clinic visits?
Are you willing to try different types of inhalers as directed by the study team?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be part of it for about four weeks. During this time, you will try different treatments: the current Trixeo inhaler, the new Trixeo inhaler, and a dummy inhaler (placebo). You won't know which one you're using at any given time, and neither will the study doctors – this helps keep the results fair.

You'll have several visits to the clinic where doctors will check your general health, measure your breathing using lung function tests (like how much air you can breathe out and how fast), and ask about any side effects you might be having. You'll switch between the different inhalers according to a set plan during the study period. There will also be follow-up checks to make sure you're doing well after the study treatments.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving specific medical attention and being monitored closely by a healthcare team. You might also gain access to a new version of medication that could potentially help your breathing. However, there's always a chance that the treatment might not help you, or you could experience side effects, just like with any medication. The study will carefully monitor for any side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Hungary
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Unverified
Bulgaria
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Unverified
Poland

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a lung condition that makes it hard to breathe because your airways are narrowed and inflamed.

What is an inhaler?

An inhaler is a device that delivers medicine directly into your lungs when you breathe in. It's often used to treat conditions like COPD.

What does 'placebo' mean?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers see if the actual medicine truly makes a difference.

Why are there two different Trixeo inhalers being tested?

Researchers want to see if a slightly different version of the inhaler, perhaps using a new propellant, works just as well as the current one. This could lead to better or more sustainable treatment options in the future.

How long will the study last?

The main part of the study where you're trying different inhalers will last about four weeks, plus any follow-up appointments.